Australia - Drug Information Association

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Australia 

Australia - Safety Advisory: Information on the LCS Duofix Femoral Knee 

Replacement Component Recall, 01-Oct-2010 

With this advisory the Therapeutic Goods Administration (TGA) provides information to consumers about the recall and the 

TGA's regulatory activities in relation to the product LCS Duofix Femoral Knee Replacement Component. The TGA has 

approved the recall of this product on 24-July 2009 in response to an increasing, but still low, number of patients needing to 

have the implant replaced. The TGA reminds that the product was subsequently cancelled from the Australian Register of 

Therapeutic Goods (ARTG) on 13-Jan-2010. The TGA informs that to date it has received 125 adverse event reports for this 

product and advises consumers to contact the surgeon who performed their knee replacement surgery in case they 

experience ongoing and unexplained symptoms of pain and swelling around the knee joint, or have any additional questions 

regarding this matter. 

Document date : 01-Oct-2010 

Type of text : Advisory, Safety Information 

Regulatory version : None 

Language : English 

Australia - Safety Alert: Sibutramine (Reductil) – Withdrawal in Australia, 08- 

Oct-2010 

With this alert the Therapeutic Goods Administration (TGA) annouces the withdrawal from Australian market of sibutramine 

(Reductil) marketed by Abbott Australasia, from 09-Oct-2010 due to a higher rate of cardiovascular events in obese and 

overweight patients using this product. Sibutramine (Reductil) is a prescription medicine indicated for weight loss. 


Type of text : Alert, Safety Information 



Australia - Technical Guidance on Interpretation of Manufacturing Standards: 

On-Going Stability Testing for Listed Complementary Medicines, Issue 1, 30-Jun- 

2010 

This Guidance has been issued by the Technical Working Group (TWG) on Complementary Medicines established by the 

TGA's Office of Manufacturing Quality (OMQ). This Guidance is intended to clarify the interpretation of the cGMP Standard 

requirements in relation to on-going stability testing requirements for listed complementary medicines. This Guidance is not 

mandatory or enforceable under law. It is not intended to be restrictive. It describes a way that a manufacturer may 

operate to demonstrate compliance with the relevant Code of Good Manufacturing Practice (Medicinal Products). 

Comment: This document replaces Draft Technical Guidance on the Interpretation of Manufacturing Standards: On-Going 

Stability Testing for Listed Complementary Medicines, Issue 12, 01-Mar-2010. 

Document date : 30-Jun-2010 

Type of text : Guideline 

Regulatory version : Final 


Australia - Technical Guidance on Interpretation of Manufacturing Standards: 

Product Quality Review for Listed Complementary Medicines, Issue 1, 30-Jun- 

2010 

This guidance has been issued by the Technical Working Group (TWG) on Complementary Medicines established by the 

TGA’s Office of Manufacturing Quality (OMQ). This guidance is intended to clarify the interpretation of the PIC/S Guide to 

Good Manufacturing Practice for Medicinal Products (88687) in relation to the conducting of product quality reviews for listed

complementary medicines. Product Quality Reviews have become an accepted part of GMP requirements internationally and 

may provide useful information and additional controls over manufacturing processes and quality requirements for products. 

Product Quality Reviews will also provide a mechanism to ensure on-going stability studies are conducted by sponsors, as 

verified during an audit of a manufacturer by reviewing the information available to the authorised person releasing product 

for supply to the market. 

Comment: This document replaces Draft Technical Guidance on the Interpretation of Manufacturing Standards: Product 

Quality Review for Listed Complementary Medicines, Issue 8, 16-Feb-2010. 

Document date : 30-Jun-2010 




Australia - Medicines Safety Update No.5, 2010, 05-Oct-2010 

In this issue of the Medicine Safety Update the Therapeutic Goods Administration (TGA) covers the following issues: - 

Cholinesterase inhibitors and syncope, - Statins, macrolides and rhabdomyolysis, - Uterine perforation with levonorgestrelreleasing 

intrauterine system (Mirena), - Rivaroxaban (Xarelto) – an overview of adverse event reports, - What to report? 


Type of text : Medicines Safety Update, Safety Information 



Australia - Advisory Committee on Non-prescription Medicines (ACNM), Updated 

07-Oct-2010 

This document provides information on the Advisory Committee on Non-prescription Medicines (ACNM). The ACNM was 

formed in January 2010 to succeed to the Medicines Evaluation Committee (MEC)(47137). ACNM’s main role is to advise 

and make recommendations to the TGA regarding the entry of non-prescription medicines on the Australian Register of 

Therapeutic Goods (the Register). The ACNM may also provide advice to the TGA on other matters concerning nonprescription 

medicines, and any other matters referred to it by the TGA. In addition, this document provides information on 

current members, meeting dates and contact details. 

Comment: The last update inludes new ACNM meeting dates for 2011. 


Type of text : Publication 



Australia - Technical Working Groups, Updated 07-Oct-2010 

This TGA publication provides information about Technical Working Groups (TWG). Technical Working Groups (TWG) have 

been established by the TGA's Office of Manufacturing Quality (OMQ) to bring together manufacturing technical expertise 

from industry and the regulator to address the grey areas or vagaries of the cGMP as it relates to manufacturing. The TWG 

are established for the following subject areas: - Blood, Tissues and Cellular Therapies - Complementary Medicines - Medical 

Devices - Non-Sterile Medicines - Pharmacy Manufacturing - Sterile Medicines - Radiopharmaceuticals sub-group. In 

addition, in this publication the TGA provides the list of current TWG members and existing interpretive guides and 

documents. 

Comment: With the update of 07-Oct-2010 two new versions of technical guidances on the interpretation of manufacturing 

standards have been added to the list of existing interpretive guides and documents. 





Australia - Questions and Answers on the Code of Good Manufacturing Practice, 

Version 8.3, 07-Oct-2010 

This document provides information on the current Code of Good Manufacturing Practice in the format of questions and 

answers. It explains reasons of the adoption of the new Code of GMP which is based on the PIC/S Guide to Good 

Manufacturing Practice for Medicinal Products, PE 009-8, 15 January 2009 (88687). The new Code of GMP has become 

mandatory from 01-Jul-2010 and replaced the Australian Code of GMP for Medicinal Products of 16-Aug-2002. This 

document also explains that the most significant change for manufacturers of medicinal products is the requirement to 

prepare annual Product Quality Reviews with detailed procedures on quality risk management, stability testing and 

reference (including retention) samples. Changes for the manufacture of sterile medicinal products are also included in 

Annex 1. Where relevant, annexes will also apply to the manufacture of APIs. In addition, this document presents the 

implications for manufacturers of sunscreens and medicinal gases. The following topics are covered in this document: - 

General issues - Quality management - Personnel - Premises and equipment - Production - Quality control - Complaints and 

product recall - Manufacture of sterile medicinal products - Manufacture of biological medicinal products - Manufacture of

adiopharmaceuticals (new) - Manufacture of herbal medicinal products - Sampling of starting and packaging materials - 

Manufacture of investigational medicinal products - Qualification and validation - Reference and retention samples 

Comment: The version of 07-Oct-2010 includes new questions and answers relating to product quality reviews, on-going 

stability program, radiopharmaceuticals and investigational medicinal products, as follows: - 8. Can the Technical Guidance 

documents that are available for Listed Complementary medicines manufacturers also be applied for sunscreen 

manufacturers? - 19. What is meant by "all licensed products" in the first sentence of Clause 1.4, stating that PQRs should 

be conducted for all licensed products? - 22. Do all batches for which manufacture has commenced have to be included in 

PQRs? - 46. Where bulk medicines are imported into Australia to be packaged by a domestic manufacturer, may the ongoing 

stability program of the bulk manufacturer be used? - Annex 3 (questions 58-60) - Manufacture of 

radiopharmaceuticals; - 67. What is meant by "certain characteristics" in clause 32 of Annex 13? 


Type of text : Questions & Answers 



Australia - Australian Technical Advisory Group on Immunisation (ATAGI) and 

Therapeutic Goods Administration (TGA) Joint Working Group: Report of an 

Analysis of Febrile Convulsions Following Immunisation in Children Following 

Monovalent Pandemic H1N1 Vaccine (Panvax/Panvax Junior, CSL), 28-Sep-2010 

This report has been developed by ATAGI – TGA joint working group after re-examination of the rate of febrile convulsions 

following administration of the monovalent pandemic H1N1 influenza vaccine, Panvax/Panvax Junior (CSL) in young 

children. This report addresses the following questions: 1. Is the rate of early onset systemic adverse reactions (ie fever, 

febrile convulsions) in Panvax/Panvax Jnr recipients aged less than 5 years, and particularly in those less than 3 years, 

higher than expected? 2. If the rate of adverse events following immunisation (AEFI) post–Panvax/Panvax Jnr is higher than 

expected, is this sufficient to alter the overall risk/benefit profile of the use of Panvax/Panvax Jnr? 3. If the risk/benefit 

profile of Panvax/Panvax Jnr is unfavourable, do the findings alter the recommendations for use of Panvax in this age group 

and if so how? In conclusion, this report states that the rate of adverse events is acceptable, in light of the overall benefits 

anticipated by vaccination against pandemic H1N1 influenza, and remains within the specified range stated within the 

Panvax Product Information. 

Document date : 28-Sep-2010 

Type of text : Report, Safety Information 



Australia - Suspected Adverse Reactions to Panvax Reported to the TGA 30 

September 2009 to 17 September 2010, Updated 06-Oct-2010 

This document has been issued by the Therapeutic Goods Administration of Australia (TGA) to provide information about 

adverse reactions reported following the national immunisation program with Panvax from 30-Sep-2009 to 17-Sep-2010. 

The great majority of reported side effects have been mild and common problems, such as headache, gastrointestinal upset, 

soreness, swelling, or redness at the injection site. The TGA's assessment remains that Panvax is a safe, effective vaccine 

for prevention of the H1N1 influenza. 

Comment: The update of 06-Oct-2010 includes additional details on received reports of febrile convulsions in children 

following Panvax/Panvax Jr administration, and information relating to the new Analysis of Febrile Convulsions Following 

Immunisation in Children Following Monovalent Pandemic H1N1 Vaccine (Panvax®/Panvax Junior®, CSL) Report (114106). 


Type of text : Safety Information 



Austria 

Austria - Federal Office For Health Care Safety (BASG): Safety Information of 25- 

Aug-2010 on Reports of Occurrence of Gastro-Intestinal Perforations Associated 

With the Use of RELISTOR (Methylnaltrexone Bromide) 

Product Name: RELISTOR INN: methylnaltrexone bromide Pharmaceutical form: solution for injection Route of 

administration: subcutaneous use Used for treatment: of opioid-induced constipation in advanced illness patients who are 

receiving palliative care when response to usual laxative therapy has not been sufficient. MA holder: Wyeth Following postmarketing 

reports of gastro-intestinal perforations in patients who had received a subcutaneous injection of RELISTOR 

(methylnaltrexone bromide), the AGES PharmMed recommends Healthcare Professionals: - to use RELISTOR with caution in 

patients with known or suspected lesions of the gastro-intestinal tract. - to advise them to promptly notify their physician if 

they develop severe, persistent, and/or worsening abdominal symptoms. Sections 4.4 “Special Warnings and Precautions for 

Use” and 4.8 “Adverse Drug Reactions” (post-marketing experience) of the product information (SmPC) were updated

accordingly. The revised SmPC in German language is attached to this Dear Doctor Letter. 

Document date : 25-Aug-2010 

Type of text : BASG Safety Information 


Language : German 


Sep-2010 Potential Risk of Life-Threatening Air or Gas Embolism with the Use of 

Spray Devices Employing Pressure Regulator to Administer TISSEEL (Solution for 

Tissue Sealant) 

Product Name: TISSEEL INN: fibrinogen Pharmaceutical Form: solution for tissue sealant Used for treatment: as supportive 

treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis Marketing 

Authorization Holder: Baxter The Federal Office For Health Care Safety (BASG) wishes to make Healthcare Professionals 

aware of new safety information regarding the risk of gas or air embolism associated with the use of spray application 

devices in conjunction with a pressure regulator for the administration of fibrin sealant. These events appear to be related 

to use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. Therefore, 

the product information (safety warning) has been updated in order to include the instructions for proper use of fibrin 

sealants with a spray device in order to avoid air or gas embolism. 






Sep-2010 on the Suspension of Marketing Authorization of Rosiglitazone- 

Containing Medicinal Products 

Product Name: AVANDIA, AVANDAMET, AVAGLIM INN: rosiglitazone, rosiglitazone + metformin, rosiglitazone + glimepiride 

Marketing Authorization Holder: GSK The European Medicines Agency’s Committee for Medicinal Products for Human Use 

(CHMP) has concluded that the benefits of rosiglitazone do no longer outweigh its risks, and that the marketing 

authorization for all rosiglitazone-containing medicinal products should be suspended across the European Union (EU). In 

agreement with the EMA and the CHMP, GSK recommends doctors to stop prescribing rosiglitazone-containing medicinal 

products and to switch the treatment of patients currently taking rosiglitazone to other alternative therapies. Patients who 

are currently taking rosiglitazone are advised not to stop their treatment without speaking to their Doctor and to discuss 

with him suitable alternative treatments. 





Austria - AGES PharmMed: Switch of the AGES PharmMed Pharmacovigilance 

Database – 27-Sep-2010 

The BASG/AGES PharmMed wishes to inform about a switch from Web Trader to E2B gateway system expected in October. 

This internal switch doesn’t affect MA Holders, who have already completed with success the test phase of ICSR/ADR 

electronic reporting to the organization ID: BASGAGES, BASGAGESCT. They are not required to undergo another testing 

phase. Should a Sender receive no positive acknowledgement (ACK) within two working days after submission, he is 

advised to refer to the corresponding Frequently Asked Questions (73389). 


Type of text : Other texts 



Belgium 

Belgium - AFMPS/FAGG Press Release (01-Oct-2010): ROTATEQ - Positive 

Benefit-Risk Balance (Dutch, French and English Versions) 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has reassessed 

ROTATEQ following the detection of DNA fragments of porcine circovirus (PCV) in this preventive vaccine against 

gastroenteritis due to rotavirus infection. The CHMP considers that these DNA fragments, which are found in very small 

quantities in ROTATEQ does not present a risk to public health. The benefit-risk balance of this vaccine remains positive. 


Type of text : Press Release 

Regulatory version : None

Language : Multilingual 

Belgium - AFMPS/FAGG Press Release (29-Sep-2010): OCTAGAM - EMA 

Recommends Suspending the Marketing Authorisation (Dutch, French & English 

Versions) 

In view of increased thrombo-embolic reactions reported following administration of OCTAGAM, which is a medicine 

containing 5 or 10% of normal human immunoglobulin, the Committee for Medicinal Products for Human Use (CHMP) of the 

European Medicines Agency (EMA) recommends temporarily suspending the marketing authorisation of the various 

presentations of this medicine. It also recommends that health professionals no longer use it and opt for another medicine 

containing normal human immunoglobulin. In Belgium, only OCTAGAM 5% is marketed. In agreement with the FAMHP, the 

marketing authorisation holder will proceed to recall the batches on the market. 





Brazil 

Brazil - SNVS/ANVISA/NUVIG/GFARM Alert 4: Avandia®, Risk of Cardiovascular 

Events, 29-Sep-2010 

The Brazilian Health Surveillance Agency (ANSISA) withdraws the marketing authorisation of medicinal products containing 

active ingredient rosiglitazone, in response to data that suggest an elevated risk of cardiovascular events, such as heart 

attack and stroke, congestive heart failure, brain haemorrhage and ischaemic stroke. Rosiglitazone, Avandia brand name 

and marketed by GlaxoSmithKline Brasil, belongs to the thiazolidinedione class and was used to improve glycemic control in 

patients suffering from type 2 diabetes. ANVISA advises health professionals to provide patients with other medicinal 

products than AVANDIA and report adverse drug reactions through the NOTIVISA electronic mail in the ANVISA web site. 

Furthermore, ANVISA advises patients to seek advice from health professionals and report on adverse drug reactions, if 

existing. 


Type of text : Alert 


Language : Portuguese 

Brazil - ANVISA Information Note: ANVISA Sets in Motion Electronic Labels for 

Medicinal Products’ Safety, 06-Oct-2010 

ANVISA takes new measures to reduce risks on falsified medicines. From January 2012, Casa de Moeda do Brasil (The Mint 

of Brazil) shall provide labels to make public aware of the authenticity of medicinal products at the time of purchase. These 

labels are invisible and will be located on the secondary packaging of medicinal products. They will include an individual 

non-repetitive numbering scheme to identify each medicine and to be recognised by reliable optical readers at public 

disposal in all pharmacies and drugstores of Brazil. Law 11.903, establishing an electronic system to track the 

manufacturing and the use of medicinal products, was passed to enhance the track and authenticity systems of medicines. 

This electronic system is planned to be operative by January 2012. 

Comment: This document should be read together with Law 11.903: Establishes an Electronic System to Track the 

Manufacturing and the Use of Medicinal Products,14-Jan-2009 (88235). 


Type of text : Information note 



Brazil - ANVISA Information Note: Electronic Submission of New Medicinal 

Products, 05-Oct-2010 

The Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) provides a new system to 

submit marketing authorisation applications electronically. This new system enables to reduce pharmaceutical companies’ 

costs and get quicker technical analysis and high-quality information protection. Notwithstanding, the level of technical 

demand is on the same track: manufacturers must prove their medicinal products meet safety, efficacy and quality 

requirements to get the marketing authorisation. At first, only applications for new active-ingredient products will be 

submitted on line. This electronic system represents the first innovation among ANVISA’s on-line services and through the 

new documents’ management programme (Programa de Gestão Documental, GED), ANVISA will provide documents in 

digital format in the future. 


Type of text : Information note 



Canada 

Canada - Newsletter: Canadian Adverse Reaction Newsletter - Vol.20, No.4, Oct- 

2010 

Highlights of October 2010 Adverse Reaction Newsletter: - Statins and interstitial lung disease, - Potential interference of 

computed tomography(CT) scanning with electronic medical devices, - Case presentation: Red Bull Energy Drink and 

suspected association with seizure, - New consumer form for reporting adverse reactions, - Summary of advisories. 

Document date : Oct-2010 

Type of text : Canadian Adverse Drug Reaction Newsletter, Letter, Newsletter 



Canada - Health Canada Advisory: Ongoing Review of Calcium Supplements, 05- 

Oct-2010 

With this document Health Canada is informing it is conducting an ongoing review of the benefits and risks associated with 

taking calcium supplements. This communication is issued in light of public interest and media reports regarding a study 

published in the British Medical Journal that identified a potential link between the use of calcium supplements (used 

without supplementary vitamin D) and an increased risk of cardiovascular events, such as heart attack, in patients with, or 

at risk of, osteoporosis. According to Health Canada, the study does not demonstrate a conclusive association between 

calcium supplementation and cardiovascular risks. The agency will continue to evaluate new data as they emerge and will 

take appropriate action as necessary. 


Type of text : Health Canada Advisory 



Canada - Health Canada’s Position Statement on the Preclearance & Complaint 

Adjudication of Exempted Natural Health Product Advertising Materials, 30-Sep- 

2010 

This statement applies to advertising of natural health products (NHPs) for which an exemption number has been issued by 

Health Canada under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) 

(112134). This position statement will be in effect strictly for the duration of the NHP-UPLAR and will be annulled once the 

NHP-UPLAR are repealed. Advertising preclearance agencies, in accordance with their established procedures, will perform 

the preclearance and complaint adjudication of advertising materials pertaining to exempted NHPs. Instead of the product 

licence, the product licence application form submitted to Health Canada will temporarily serve as the terms of market 

authorization. 





Canada - Register of Innovative Drugs, Updated 06-Oct-2010 

This update of the list of products for human use includes addition of the following drug: - Vimpat (lacosamide). The 

Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations (24023). The register 

indicates the drugs that are eligible for data protection. It is maintained by the Minister of Health and updated regularly. It 

lists: - drug by name - medicinal ingredient and brand name - manufacturer's name - dates of NOC - 6-year "no file" dates - 

Pediatric extension or not - dates of end of data protection 





Canada - Good Manufacturing Practices Questions & Answers, Updated Oct-2010 

The Good Manufacturing Practices questions and answers document is updated on a regular basis. This revision follows the 

issuance of the “Good Manufacturing Practices Guidelines, 2009 Edition (GUI-0001)” (91881). Some Q&As have been 

deleted because they have been incorporated in GUI-0001. Some Q&As have been modified as a result of the revision of 

GUI-0001. Also, the majority of the Q&As have been renumbered. 





Canada - Record of Decisions: Canadian Society of Hospital Pharmacists (CSHP) 

and Health Canada, 11-Mar-2010 

Topics discussed at the meeting include: 1. Welcome and Introductions 2. Review of Agenda 3. Approval of the March 5, 

2009 Meeting Notes 4. Change in Licensing Status from Drugs to Natural Health Products 5. Designation of Pharmacists as 

Practitioners under the Controlled Drugs and Substances Act 6. MedEffect Canada Social Marketing Campaign 7. National 

Pharmaceuticals Strategy (NPS) (62936) 8. Look-alike Sound-alike (LASA) Health Product Names 9. Drug Package and 

Label Design 10. Roundtable 11. Adjournment and Next meeting. 

Document date : 11-Mar-2010 

Type of text : Record of Decisions 



Canada - Canadian Environmental Protection Act, 1999: Publication after 

Screening Assessment of Substances and Publication of Results of Investigations 

and Recommendations for a Substance — Batches 6, 8, 11 - Gazette Part I, 02- 

Oct-2010 (English & French Versions) 

Minister of the Environment and Minister of Health published in the Canada Gazette, Part I, decisions after screening 

assessment of 20 substances and results of investigations and recommendations for one substance in the batches 6, 8 and 

11 of substances specified on the Domestic Substances List of the Canadian Environmental Protection Act, 1999. The 

concerned substances are following: - 1-[[4-(phenylazo)phenyl]azo]- 2-Naphthalenol (Solvent Red 23), - 2,7- 

Naphthalenedisulfonic acid, 3-[[2,2′-dimethyl-4′-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl]azo]- 

4-hydroxy-, disodium salt (Acid Red 111), - Phenol, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]- (Disperse Orange 

29), - Butanamide, 2,2′-[(3,3′-dimethoxy[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxo-(BPAOPB), - 

Phosphonic acid, [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]-, monoethyl ester, calcium salt (2:1), - Hexanedioic 

acid, bis(2-ethylhexyl) ester, - 2-Propanone, reaction products with diphenylamine, - 1,4-Benzenediamine, N,N′-mixed tolyl 

and xylyl derivs., - 1,4-Benzenediamine, N,N′-mixed Ph and tolyl derivs., - 2-Furancarboxaldehyde, - 2-Propenoic acid, 

ethyl ester, - Hexanoic acid, 2-ethyl-, - Siloxanes and Silicones, Me 3,3,3-trifluoropropyl, Me vinyl, hydroxy-terminated - 

Siloxanes and Silicones, di-Me, hydrogen-terminated, - Bismuthine, triphenyl-, - Cyclotetrasiloxane, heptamethylphenyl-, - 

Benzene, 1,1 ′ -(chlorophenylmethylene)bis[4-methoxy-, - Phenol, 2-phenoxy-, trichloro deriv., - Siloxanes and Silicones, 

di-Me, reaction products with Me hydrogen siloxanes and 1,1,3,3-tetramethyldisiloxane, - Phenol, 4,4 -(1methylethylidene)bis-, 

reaction products with hexakis(methoxymethyl)melamine, - Ethanedial, CAS No. 107-22-2. 

Comment: Public comment period is open within 60 days after the publication. 


Type of text : Regulations 



Canada - Regulations: Proposed Regulations Prepublished in Canada Gazette 

Part I - Order Adding Toxic Substances to Schedule 1 to the Canadian 

Environmental Protection Act, 1999, 02-Oct-2010 (English &French Versions) 

The objective of the proposed Order is to add the following substances to the List of Toxic Substances in Schedule 1 of 

Canadian Environmental Protection Act (28610). - Propane, 2-nitro-, which has the molecular formula C3H7NO2 - Benzene, 

1-methyl-2-nitro-, which has the molecular formula C7H7NO2 - Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)-, 

which has the molecular formula C18H30O - Methylium, [4-(dimethylamino)phenyl]bis[4-(ethylamino)-3-methylphenyl]-, 

acetate, which has the molecular formula C27H34N3.C2H3O2. Any person may, within 60 days after the date of publication 

of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of 

objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the 

objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be 

sent by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, 

Gatineau, Quebec K1A 0H3, by fax to 819-953-7155 or by email to Existing.Substances.Existantes@ec.gc.ca. 


Type of text : Regulations 

Regulatory version : Draft 


Chile 

Chile - ISP Safety Alert on Rosiglitazone & Cardiovascular Adverse Events, 29- 

Sep-2010 

Following scientific information revealing higher risks of cardiovascular adverse events associated with the use of

osiglitazone, the European Medicines Agency (EMA) suspended the marketing authorization of all the pharmaceutical 

products containing this active ingredient, and the American Food and Drug Administration (FDA) implemented restrictions 

on its use. Till now, the Chilean National Pharmacovigilance Centre (CENIMEF) has registered seven cases of possible 

adverse events associated with the use of rosiglitazone, but none of them was related to cardiac problems. While deeply 

analyzing the information available on the active ingredient rosiglitazone, the Public Health Institute aims at implementing a 

strategy to safely use this drug. As a consequence, the marketing authorizations holders must update the product 

information to be provided to the professionals and patients by including this new safety information. Doctors must monitor 

the current treatments with rosiglitazone, and all health professionals are invited to report to the CENIMEF any possible 

adverse event associated with the use of this active ingredient. 


Type of text : Alert 


Language : Spanish 

Chile - Chilean Government Announces Working Table to Regulate 

Biotechnological Drugs, 01-Oct-2010 

A working table aiming at regulating the biotechnological drugs will be organized around the middle of the year 2011, with 

the participation of the Ministry of Heath, the Health Public Institute and the pharmaceutical industry. Biopharmaceuticals 

are drugs whose active ingredients are made from a living organism and transformed through technology. As a 

consequence, the manufacturing process requires a higher surveillance and control. Over the last ten years, biotechnological 

drugs have become one of the most important solutions to treat diseases such as diabetes and cardiovascular diseases. 

With a better efficacy and safety than traditional chemical drugs, they could represent the future of drugs in the world. The 

upcoming working table will match the Health Public Institute priority consisting in having quality drugs in Chile. At the 

same time, efforts will be made to implement active prevention regarding the public health and pharmaceutical companies 

of excellence, as well as to improve research and technology in the health public sector. 


Type of text : Communication 


Language : Spanish 

China 

China - Notification: GuoShiYaoJianZhu[2010]387: Notification on CTD Format 

for Drug Registration, 25-Sep-2010(Chinese version) 

To improve the quality and level of drug development as well as to consider the harmonisation of international standards, 

SFDA announces the use of CTD format for an application of drug registration. Details of organisation of CTD format are 

provided. CTD format should be used to comply with SFDA Order No. 28: Regulations on Drug Registration Administration, 

Revision, 10-Jul-2007 (71282).Some remarks on use of CTD within the regulations of SFDA Order No. 28 include; For Annex 

2 Classification and Requirements of Registration for Chemical Medicinal Product, 3, 4, 5 and 6 parts of an application for 

registration of medicinal product may be submitted based on CTD format, and submitted electronically. For clinical trials 

application for Category 1 and 2, CTD format is not accepted for the moment. 


Type of text : Notification 


Language : Chinese 

Colombia 

Colombia - INVIMA Alert 006-10: INVIMA Suspends the Marketing Authorization 

and Use of Rosiglitazone in Colombia, 29-Sep-2010 

After evaluating the benefit-risk balance of rosiglitazone, closely associated with cardiovascular adverse events, the INVIMA 

decided to suspend the marketing authorization for all the drugs containing this active ingredient. Rosiglitazone is used for 

Type 2 Diabetes Mellitus, but other types of drugs can be used as an alternative to the higher risks associated with this 

active ingredient. Current treatments with rosiglitazone should closely be monitored by the doctors, but must not be 

abruptly interrupted. Both health professionals and patients are invited to report any adverse event using the 

Pharmacovigilance System implemented by the INVIMA. 

Comment: The previous document in which the INVIMA advised about the risks associated to rosiglitazone: New Safety 

Information Related to the Use of Rosiglitazone, 27-Sep-2010, is available in IDRAC (113747). 




Language : Spanish

Denmark 

Denmark - Fees 

This document provides information on fees. 


Type of text : Explanatory 


Denmark - Guideline: Applications for Authorisation of Clinical Trials of Medicinal 

Products on Humans, Oct-2006, updated 23-Sep-2010 

This document describes in detail how to apply for approval of a clinical trial in humans in Denmark. The information 

comprise the following: the regulations, the fee, how to apply, the content of the application, the trial protocol, GCP, 

documentation to append to the application, labelling, distribution and sales, information to the patient, starting and 

termination of the trial including information on how to handle changes, reporting serious adverse events, how to report the 

results. The guidelines also contain 11 appendices consisting of excerpts from the regulations and the various forms to be 

completed. 

Comment: This guideline replaces the previous version of 03-Sep-2010 (112846). 



Regulatory version : Revision 

Language : Danish 

European Union 

European Union - EMA Press Release EMA/613458/2010: European Medicines 

Agency Awards First ENCePP Study Seal for Post-Marketing Study, 01-Oct-2010 

A new seal has been awarded by the European Medicines Agency and the European Network of Centres for 

Pharmacoepidemiology and Pharmacovigilance (ENCePP) to a transparent, independent observational study in patients with 

chronic obstructive pulmonary disease. 


Type of text : EMA Press Release, Press Release 



European Union - European Medicines Agency Receives 1,000th Application for a 

Paediatric Investigation Plan or Waiver, 08-Oct-2010 

This document provides information on the 1,000th application for a PIP or waiver since Jul-2007 when the PDCO was 

created. 


Type of text : EMA Press Release, Press Release 



European Union - EMA EPAR EMEA/H/C/000275 Revision 18: KOGENATE BAYER 

(octocog alfa (recombinant coagulation factor VIII)) 

Name of the medicinal product: KOGENATE BAYER - International Nonproprietary Name: octocog alfa (recombinant 

coagulation factor VIII) - Marketing Authorisation Holder: Bayer Schering Pharma AG - Pharmaco-therapeutic group - (ATC 

Code): - Therapeutic indication(s): + Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital 

factor VIII deficiency). + This preparation does not contain von Willebrand factor and is therefore not indicated in von 

Willebrand's disease. - Pharmaceutical form: Powder and solvent for solution for injection - Route of administration: 

Intravenous use - Packaging: + powder: vial (glass) + solvent: pre-filled syringe (glass) Risk Management Plan: Yes Last 

changes since the previous version of this EPAR: Major changes: - Renewal of the marketing authorisation. - Change or 

addition of a new strength/potency. - This was an application for a Type IB variation, following a worksharing procedure 

according to Article 20 of Commission Regulation (EC) No 1234/2008. Stability of FP – Extension of the shelf life of the 

finished product - Extension of storage period of a biological/immunological medicinal product in accordance with an 

approved stability protocol. To extend the shelf life of the product from 24 month to 30 months for the 2000 IU doses 

strength. - Change in the specification parameters and/or limits of the finished product - Change outside the approved 

specifications limits range. Change in drug product test procedure and drug product specification. Minor changes: - Change 

in the specification parameters and/or limits of an AS, starting material/intermediate/reagent - Tightening of specification 

limits. - PMF – Inclusion of a new, updated or amended PMF in the marketing authorisation dossier of a medicinal product. 

(PMF 2nd step procedure) - Inclusion of an updated/amended PMF when changes do not affect the properties of the FP. -

This was an application for a group of variations. Changes to an existing pharmacovigilance system as described in the 

DDPS - Other change(s) to the DDPS that does not impact on the operation of the pharmacovigilance system, Changes to 

an existing pharmacovigilance system as described in the DDPS - Change in the QPPV, Changes to an existing 

pharmacovigilance system as described in the DDPS - Change in the contact details of the QPPV, Changes to an existing 

pharmacovigilance system as described in the DDPS - Change of the back-up procedure of the QPPV. NB: This exclusive 

document has been prepared by IDRAC by integrating the seven or eight files released in English by the EMEA into one 

comprehensive document. Consequently, the page numbering is not in sequence, but has been left so that the user can 

appreciate the reorganisation done by IDRAC. It is also enriched by a detailed Table of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on KOGENATE BAYER (octocog alfa (recombinant 

coagulation factor VIII)): EMEA/H/C/275 Revision 17 (108711). 


Type of text : EPAR 



European Union - EMA EPAR EMEA/H/C/000276 Revision 19: HELIXATE NEXGEN 

(octocog alfa (recombinant coagulation factor VIII)) 

Name of the medicinal product: HELIXATE NEXGEN - International Nonproprietary Name: octocog alfa (recombinant 

coagulation factor VIII) - Marketing Authorisation Holder: Bayer Schering Pharma AG - Pharmaco-therapeutic group - (ATC 

Code): Antihemorrhagics: blood coagulation factor VIII - (B02BD02) - Therapeutic indication(s): + Treatment and 

prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). + This preparation does not 

contain von Willebrand factor and is therefore not indicated in von Willebrand's disease. - Pharmaceutical form: Powder and 

solvent for solution for injection - Route of administration: Intravenous use - Packaging: + powder: vial (glass) + solvent: 

vial (glass) Risk Management Plan: Yes Last changes since the previous version of this EPAR: Major changes: - Renewal of 

the marketing authorisation - Change or addition of a new strength/potency. - This was an application for a Type IB 

variation, following a worksharing procedure according to Article 20 of Commission Regulation (EC) No 1234/2008. Stability 

of FP – Extension of the shelf life of the finished product - Extension of storage period of a biological/immunological 

medicinal product in accordance with an approved stability protocol. To extend the shelf life of the product form 24 months 

to 30 months for the 2000 IU doses strength. - Change in the specification parameters and/or limits of the finished product 

- Change outside the approved specifications limits range. Change in drug product test procedure and drug product 

specification. Minor changes: - Change in the specification parameters and/or limits of an AS, starting 

material/intermediate/reagent - Tightening of specification limits. - PMF – Inclusion of a new, updated or amended PMF in 

the marketing authorisation dossier of a medicinal product. (PMF 2nd step procedure) - Inclusion of an updated/amended 

PMF when changes do not affect the properties of the FP. - This was an application for a group of variations. Changes to an 

existing pharmacovigilance system as described in the DDPS - Other change(s) to the DDPS that does not impact on the 

operation of the pharmacovigilance system, Changes to an existing pharmacovigilance system as described in the DDPS - 

Change in the QPPV, Changes to an existing pharmacovigilance system as described in the DDPS - Change of the back-up 

procedure of the QPPV, Changes to an existing pharmacovigilance system as described in the DDPS - Change in the contact 

details of the QPPV. NB: This exclusive document has been prepared by IDRAC by integrating the seven or eight files 

released in English by the EMEA into one comprehensive document. Consequently, the page numbering is not in sequence, 

but has been left so that the user can appreciate the reorganisation done by IDRAC. It is also enriched by a detailed Table 

of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on HELIXATE NEXGEN (octocog alfa (recombinant 

coagulation factor VIII)): EMEA/H/C/276 Revision 18 (108685). 





European Union - EMA EPAR EMEA/H/C/000277 Revision 20: KEPPRA 

(levetiracetam) 

Name of the medicinal product: KEPPRA - International Nonproprietary Name: levetiracetam - Marketing Authorisation 

Holder: UCB Pharma SA - Pharmaco-therapeutic group - (ATC Code): Antiepileptics, other antiepileptics - (N03AX14) - 

Therapeutic indication(s): + KEPPRA is indicated as monotherapy in the treatment of partial onset seizures with or without 

secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. + KEPPRA is indicated as 

adjunctive therapy ++ in the treatment of partial onset seizures with or without secondary generalisation in adults, children 

and infants from 1 month of age with epilepsy. ++ in the treatment of myoclonic seizures in adults and adolescents from 12 

years of age with Juvenile Myoclonic Epilepsy. ++ in the treatment of primary generalised tonic-clonic seizures in adults and 

adolescents from 12 years of age with Idiopathic Generalised Epilepsy. - Pharmaceutical form: + Film-coated tablet + Oral 

solution + Concentrate for solution for infusion - Route of administration: + Oral use + Intravenous use - Packaging: + 

blister + bottle + vial Risk Management Plan: Yes Last changes since the previous version of this EPAR: Major changes: - 

There have been no major changes. Minor changes: - There have been no minor changes. NB: This exclusive document has 

been prepared by IDRAC by integrating the seven or eight files released in English by the EMEA into one comprehensive 

document. Consequently, the page numbering is not in sequence, but has been left so that the user can appreciate the 

reorganisation done by IDRAC. It is also enriched by a detailed Table of Contents provided in the left frame.

Comment: This document replaces the previous version of the EPAR on KEPPRA (levetiracetam): EMEA/H/C/000277 

Revision 19 (113509). 





European Union - EMA EPAR EMEA/H/C/000285 Revision 18: ACTOS 

(pioglitazone) 

Name of the medicinal product: ACTOS - International Nonproprietary Name: pioglitazone - Marketing Authorisation Holder: 

Takeda Global Research and Development Centre (Europe) Ltd - Pharmaco-therapeutic group - (ATC Code): Drugs used in 

diabetes, blood glucose lowering drugs, excl. insulins - (A10BG03) - Therapeutic indication(s): + Pioglitazone is indicated in 

the treatment of type 2 diabetes mellitus: ++ as monotherapy: +++ in adult patients (particularly overweight patients) 

inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or 

intolerance ++ as dual oral therapy in combination with: +++ metformin, in adult patients (particularly overweight 

patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin +++ a 

sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with 

insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea. ++ as triple oral 

therapy in combination with: +++ metformin and a sulphonylurea, in adult patients (particularly overweight patients) with 

insufficient glycaemic control despite dual oral therapy. + Pioglitazone is also indicated for combination with insulin in type 2 

diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because 

of contraindications or intolerance (see section 4.4). - Pharmaceutical form: Tablet - Route of administration: Oral use - 

Packaging: blister Risk Management Plan: Yes Last changes since the previous version of this EPAR: Major changes: - 

Renewal of the marketing authorisation. Minor changes: - This was an application for a group of variations. Administrative 

change - Deletion of manufacturing sites, Change in the manufacturer of AS or of a starting material/reagent/intermediate 

for AS - Other variation, Administrative change - Change in the name and/or address of a manufacturer or supplier of the 

active substance, starting material, reagent or intermediate used in the manufacture of the active substance, Change in test 

procedure for active substance or starting material/reagent/intermediate - Minor changes to an approved test procedure. 

NB: This exclusive document has been prepared by IDRAC by integrating the seven or eight files released in English by the 

EMEA into one comprehensive document. Consequently, the page numbering is not in sequence, but has been left so that 

the user can appreciate the reorganisation done by IDRAC. It is also enriched by a detailed Table of Contents provided in 

the left frame. 

Comment: This document replaces the previous version of the EPAR on ACTOS (pioglitazone): EMEA/H/C/285 Revision 17 

(110399). 





European Union - EMA EPAR EMEA/H/C/000679 Revision 13 : THELIN 

(sitaxentan sodium) 

- Name of the medicinal product: THELIN - International Nonproprietary Name: sitaxentan sodium - Marketing Authorisation 

Holder: Pfizer Limited - Pharmaco-therapeutic group - (ATC Code): Other antihypertensives - (C02KX03) - Therapeutic 

indication(s): Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to 

improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension 

associated with connective tissue disease. - Pharmaceutical form: Film-coated tablet - Route of administration: Oral use - 

Packaging: + blister + bottle Orphan medicinal product designation date : 21 October 2004 Risk Management Plan: Yes Last 

changes since the previous version of this EPAR: Major changes: - Transfer of Marketing Authorisation Holder. - Update of 

Summary of Product Characteristics. Update of Summary of Product Characteristics, Annex II and Annex IV. Minor changes: 

- There have been no minor changes. NB: This exclusive document has been prepared by IDRAC by integrating the seven or 

eight files released in English by the EMEA into one comprehensive document. Consequently, the page numbering is not in 

sequence, but has been left so that the user can appreciate the reorganisation done by IDRAC. It is also enriched by a 

detailed Table of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on THELIN (sitaxentan sodium): EMEA/H/C/679 

Revision 12 (102741). 





European Union - EMA EPAR EMEA/H/C/000982 Revision 5: CELVAPAN 

(pandemic influenza vaccine (H1N1) (whole virion, Vero cell derived, 

inactivated)) 

- Name of the medicinal product: CELVAPAN - International Nonproprietary Name: pandemic influenza vaccine (H1N1)

(whole virion, Vero cell derived, inactivated) - Marketing Authorisation Holder: Baxter AG - Pharmaco-therapeutic group - 

(ATC Code): Influenza vaccines - (J07BB01) - Therapeutic indication: + Prophylaxis of influenza in an officially declared 

pandemic situation (see sections 4.2 and 5.1). + Pandemic influenza vaccine should be used in accordance with Official 

Guidance. - Pharmaceutical form: Suspension for injection - Route of administration: Intramuscular use - Packaging: Vial 

(glass) Risk Management Plan: Yes Last changes since the previous version of this EPAR: Major changes: - Change of status 

of the Marketing Authorisation outside the scope of Art. 14(8) of Regulation (EC) No 726/2004 and change of the indication 

to include use outside of the clinical setting of an influenza pandemic. - Implementation of change(s) requested following 

the assessment of an USR, class labelling, a PSUR, RMP, FUM/SO, data submitted under A 45/46, or amendments to reflect 

a Core SPC - Change(s) with new additional data submitted by the MAH Update of section 4.8 of the SmPC to reflect safety 

data of SO2 028.4 (abridged report for post-dose 2 safety and immunogenicity data from paediatric H1N1 study 820903), 

S-PSUR 4 and preliminary data from observational study 820901. The PL has been updated accordingly. In addition the MAH 

took this opportunity to update the PI to reflect safety data of SO2 027.2 (abridged report for post-dose 2 safety and 

immunogenicity data from adult H1N1 study 820902). Annex II has also been updated to reflect the current status of the 

specific obligations. - Update of Summary of Product Characteristics and Package Leaflet Update of sections 4.2 and 5.1 of 

the SmPC based on clinical study results (920903) with Celvapan containing 7.5µg H1N1 antigen of the 

A/H1N1/California/07/2009 influenza virus in infants, children and adolescent aged 6 months to 17 years. Section 3 of the 

PL has been updated accordingly. - Update of Summary of Product Characteristics and Package Leaflet Update of sections 

4.2 and 5.1 of the SmPC based on clinical study results (study 920902) with Celvapan containing 7.5µg H1N1 antigen of the 

A/H1N1/California/07/2009 influenza virus in adults and elderly. The PL has been updated accordingly. Minor changes: - 

There have been no minor changes. NB: This exclusive document has been prepared by IDRAC by integrating the seven or 




Comment: This document replaces the previous version of the EPAR on CELVAPAN (pandemic influenza vaccine (H1N1) 

(whole virion, Vero cell derived, inactivated)): EMEA/H/C/982 Revision 4 (109301). 





European Union - EMA EPAR EMEA/H/C/1039 Revision 2: ONGLYZA (saxagliptin) 

Name of the medicinal product: ONGLYZA - International Nonproprietary Name: saxagliptin - Marketing Authorisation 

Holder: Bristol-Myers Squibb/AstraZeneca EEIG - Pharmaco-therapeutic group - (ATC Code): Dipeptidyl peptidase 4 (DPP-4) 

inhibitors - (A10BH03) - Therapeutic indication: Add-on combination therapy: + ONGLYZA is indicated in adult patients aged 

18 years and older with type 2 diabetes mellitus to improve glycaemic control: ++ in combination with metformin, when 

metformin alone, with diet and exercise, does not provide adequate glycaemic control; ++ in combination with a 

sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in 

patients for whom use of metformin is considered inappropriate. ++ in combination with a thiazolidinedione, when the 

thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a 

thiazolidinedione is considered appropriate. - Pharmaceutical form: Film-coated tablet - Route of administration: Oral use - 

Packaging: + Non-perforated blister + Perforated blister Risk Management Plan: Yes Last changes since the previous 

version of this EPAR: Major changes: - Variations related to significant modifications of the Summary of Product 

Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data Update of section 5.1 of the 

Summary of Product Characteristics (SPC) to reflect the results of an active controlled study to evaluate the efficacy and 

safety of saxagliptin in combination with metformin compared with sulphonylurea in combination with metformin. - 

Variations related to significant modifications of the Summary of Product Characteristics due in particular to new quality, 

pre-clinical, clinical or pharmacovigilance data Update of section 5.1 of the Summary of Product Characteristics to include 

the results of a study to evaluate the efficacy and safety of saxagliptin in combination with metformin compared with 

sitagliptin with metformin. Minor changes: - There have been no minor changes. NB: This exclusive document has been 

prepared by IDRAC by integrating the seven or eight files released in English by the EMEA into one comprehensive 


reorganisation done by IDRAC. It is also enriched by a detailed Table of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on ONGLYZA (saxagliptin): EMEA/H/C/1039 Revision 1 

(112701). 





European Union - EMA EPAR EMEA/H/C/1234 Revision 2: RISTABEN (sitagliptin) 

Name of the medicinal product: RISTABEN - International Nonproprietary Name: sitagliptin - Marketing Authorisation 

Holder: Merck Sharp & Dohme Ltd - Pharmaco-therapeutic group - (ATC Code): Drugs used in diabetes, Dipeptidyl 

peptidase 4 (DPP-4) inhibitors - (A10BH01) - Therapeutic indication: For patients with type 2 diabetes mellitus, RISTABEN is 

indicated to improve glycaemic control: + As monotherapy: ++ in patients inadequately controlled by diet and exercise 

alone and for whom metformin is inappropriate due to contraindications or intolerance. + As dual oral therapy in

combination with: ++ metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. 

++ a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate 

glycaemic control and when metformin is inappropriate due to contraindications or intolerance. ++ a PPARγ agonist (i.e. a 

thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do 

not provide adequate glycaemic control. + As triple oral therapy in combination with: ++ a sulphonylurea and metformin 

when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. ++ a PPARγ agonist 

and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these agents 

do not provide adequate glycaemic control. + RISTABEN is also indicated as add-on to insulin (with or without metformin) 

when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control. - Pharmaceutical form: 

Film-coated tablet - Route of administration: Oral use - Packaging: + Blister + Perforated unit dose blister Risk Management 

Plan: Yes Last changes since the previous version of this EPAR: Major changes: - Variations related to significant 

modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or 

pharmacovigilance data Minor changes: - There have been no minor changes. NB: This exclusive document has been 




Comment: This document replaces the previous version of the EPAR on RISTABEN (sitagliptin): EMEA/H/C/1234 Revision 1 

(112925). 





European Union - EMA EPAR EMEA/H/C/1235 Revision 2: RISTFOR (sitagliptin / 

metformin hydrochloride) 

Name of the medicinal product: RISTFOR - International Nonproprietary Name: sitagliptin / metformin hydrochloride - 

Marketing Authorisation Holder: Merck Sharp & Dohme Ltd. - Pharmaco-therapeutic group - (ATC Code): Drugs used in 

diabetes, Combinations of oral blood glucose lowering drugs - (A10BD07) - Therapeutic indication: For patients with type 2 

diabetes mellitus: + RISTFOR is indicated as an adjunct to diet and exercise to improve glycaemic control in patients 

inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the 

combination of sitagliptin and metformin. + RISTFOR is indicated in combination with a sulphonylurea (i.e., triple 

combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose 

of metformin and a sulphonylurea. + RISTFOR is indicated as triple combination therapy with a peroxisome proliferatoractivated 

receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients 

inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist. + RISTFOR is also indicated as 

add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in 

patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control. - Pharmaceutical 

form: Film-coated tablet - Route of administration: Oral use - Packaging: + Blister + Perforated unit dose Risk Management 

Plan: Yes Last changes since the previous version of this EPAR: Major changes: - Variations related to significant 

modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or 

pharmacovigilance data Minor changes: - There have been no minor changes. NB: This exclusive document has been 




Comment: This document replaces the previous version of the EPAR on RISTFOR (sitagliptin / metformin hydrochloride): 

EMEA/H/C/1235 Revision 1 (112916). 





European Union - EMA EPAR EMEA/H/C/157 Revision 15: CEREZYME 

(imiglucerase) 

Name of the medicinal product: CEREZYME - International Nonproprietary Name: imiglucerase - Marketing Authorisation 

Holder: Genzyme Europe B.V. - Pharmaco-therapeutic group - (ATC Code): Enzymes-Imiglucerase (recombinant 

macrophage targeted - glucocerebrosidase) - (A16AB02) - Therapeutic indication(s): + CEREZYME (imiglucerase) is 

indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic 

(Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological 

manifestations of the disease. + The non-neurological manifestations of Gaucher disease include one or more of the 

following conditions: ++ anaemia after exclusion of other causes, such as iron deficiency ++ thrombocytopenia ++ bone 

disease after exclusion of other causes such as Vitamin D deficiency ++ hepatomegaly or splenomegaly - Pharmaceutical 

form: Powder for concentrate for solution for infusion - Route of administration: Intravenous use - Packaging: Vial (glass) 

Risk Management Plan: Yes Last changes since the previous version of this EPAR: Major changes: - There have been no 

major changes. Minor changes: - There have been no minor changes. NB: This exclusive document has been prepared by 

IDRAC by integrating the seven or eight files released in English by the EMEA into one comprehensive document.

Consequently, the page numbering is not in sequence, but has been left so that the user can appreciate the reorganisation 

done by IDRAC. It is also enriched by a detailed Table of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on CEREZYME (imiglucerase): EMEA/H/C/157 Revision 

14 (113197). 





European Union - EMA EPAR EMEA/H/C/170 Revision 17: COMTESS 

(entacapone) 

Name of the medicinal product: COMTESS - International Nonproprietary Name: entacapone - Marketing Authorisation 

Holder: Orion Corporation - Pharmaco-therapeutic group - (ATC Code): Other dopaminergic agents - (N04BX02) - 

Therapeutic indication(s): Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or 

levodopa/carbidopa for use in adult patients with Parkinson’s disease and end-of-dose motor fluctuations, who cannot be 

stabilised on those combinations. - Pharmaceutical form: Film-coated tablet - Route of administration: Oral use - Packaging: 

Bottle Risk Management Plan: No Last changes since the previous version of this EPAR: Major changes: - This was an 

application for a group of variations. Variations related to significant modifications of the Summary of Product 

Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data, Implementation of change(s) 

requested following the assessment of an USR, class labelling, a PSUR, RMP, FUM/SO, data submitted under A 45/46, or 

amendments to reflect a Core SPC - Changes with NO new additional data are submitted by the MAH. The MAH submitted a 

group of variations to update the SPC sections 4.4 and 4.8 and the PL of COMTESS with respect to ischemic heart disease 

events and myocardial infarction. The SPC section 4.4 and the PL were updated further to the signal on colitis. In addition, 

the PL has been revised following the results of a user test and changes are proposed to the Annex I, IIB and IIIB of the 

COMTESS Product Information following the QRD template version 7.3. Minor changes: - Minor change in labelling or 

package leaflet not connected with the SPC (Art. 61.3 Notification). NB: This exclusive document has been prepared by 

IDRAC by integrating the seven or eight files released in English by the EMEA into one comprehensive document. 



Comment: This document replaces the previous version of the EPAR on COMTESS (entacapone): EMEA/H/C/170 Revision 

16 (95279). 





European Union - EMA EPAR EMEA/H/C/171 Revision 15: COMTAN (entacapone) 

Name of the medicinal product: COMTAN - International Nonproprietary Name: entacapone - Marketing Authorisation 

Holder: Novartis Europharm Limited - Pharmaco-therapeutic group - (ATC Code): Other dopaminergic agents - (N04BX02) - 

Therapeutic indication(s): Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or 

levodopa/carbidopa for use in adult patients with Parkinson’s disease and end-of-dose motor fluctuations, who cannot be 

stabilised on those combinations. - Pharmaceutical form: Film-coated tablet - Route of administration: Oral use - Packaging: 

Bottle Risk Management Plan: No Last changes since the previous version of this EPAR: Major changes: - This was an 

application for a group of variations. Variations related to significant modifications of the Summary of Product 

Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data, Implementation of change(s) 

requested following the assessment of an USR, class labelling, a PSUR, RMP, FUM/SO, data submitted under A 45/46, or 

amendments to reflect a Core SPC - Changes with NO new additional data are submitted by the MAH. The MAH submitted a 

group of variations to update the SPC sections 4.4 and 4.8 and the PL of COMTAN with respect to ischemic heart disease 

events and myocardial infarction. The SPC section 4.4 and the PL were updated further to the signal on colitis. In addition, 

the PL has been revised following the results of a user test, and changes are proposed to the Annex I, IIB and IIIB of the 

COMTAN Product Information following the QRD template version 7.3. Minor changes: - There have been no minor changes. 

NB: This exclusive document has been prepared by IDRAC by integrating the seven or eight files released in English by the 

EMEA into one comprehensive document. Consequently, the page numbering is not in sequence, but has been left so that 

the user can appreciate the reorganisation done by IDRAC. It is also enriched by a detailed Table of Contents provided in 

the left frame. 

Comment: This document replaces the previous version of the EPAR on COMTAN (entacapone): EMEA/H/C/171 Revision 14 

(86847). 





European Union - EMA EPAR EMEA/H/C/532 Revision 8: KENTERA (oxybutynin) 

Name of the medicinal product: KENTERA - International Nonproprietary Name: oxybutynin - Marketing Authorisation 

Holder: Nicobrand Limited - Pharmaco-therapeutic group - (ATC Code): Urinary antispasmodic - (G04B D04) - Therapeutic

indication(s): Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in 

adult patients with unstable bladder. - Pharmaceutical form: Transdermal patch - Route of administration: Transdermal use 

- Packaging: sachet Risk Management Plan: No Last changes since the previous version of this EPAR: Major changes: - 

There have been no major changes. Minor changes: - This was an application for a group of variations. Changes to an 

existing pharmacovigilance system as described in the DDPS - Change in the QPPV, Changes to an existing 

pharmacovigilance system as described in the DDPS - Change in the contact details of the QPPV. - Minor change in labelling 

or package leaflet not connected with the SPC (Art. 61.3 Notification). - This was an application for a group of variations. 

Change in the specification parameters and/or limits of the finished product Addition of a new specification parameter to the 

specification with its corresponding test method, Stability of FP – Extension of the shelf life of the finished product - As 

packaged for sale (supported by real time data). NB: This exclusive document has been prepared by IDRAC by integrating 

the seven or eight files released in English by the EMEA into one comprehensive document. Consequently, the page 

numbering is not in sequence, but has been left so that the user can appreciate the reorganisation done by IDRAC. It is also 

enriched by a detailed Table of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on KENTERA (oxybutynin): EMEA/H/C/532 Revision 7 

(106935). 





European Union - EMA EPAR EMEA/H/C/533 Revision 13: EMTRIVA 

(emtricitabine) 

Name of the medicinal product: EMTRIVA - International Nonproprietary Name: emtricitabine - Marketing Authorisation 

Holder: Gilead Sciences Intl Ltd - Pharmaco-therapeutic group - (ATC Code): Nucleoside and nucleotide reverse 

transcriptase inhibitors - (J05AF09). - Therapeutic indication(s): + EMTRIVA is indicated for the treatment of HIV-1 infected 

adults and children in combination with other antiretroviral agents. + This indication is based on studies in treatment-naïve 

patients and treatment-experienced patients with stable virological control. There is no experience of the use of EMTRIVA in 

patients who are failing their current regimen or who have failed multiple regimens (see section 5.1). + When deciding on a 

new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of 

mutations associated with different medicinal products and the treatment history of the individual patient. Where available, 

resistance testing may be appropriate. - Pharmaceutical form: + Capsule, hard + Oral solution - Route of administration: 

Oral use - Packaging: + Bottle + Blister Risk Management Plan: Yes Last changes since the previous version of this EPAR: 

Major changes: - Update of Summary of Product Characteristics and Package Leaflet Update of section 4.4 of the SmPC to 

include a recommendation not to discontinue EMTRIVA in patients co-infected with HIV and HBV with advanced liver disease 

or cirrhosis. Consequently, the PL was updated. Minor changes: - Changes to an existing pharmacovigilance system as 

described in the DDPS - Change(s) to a DDPS following the assessment of the same DDPS in relation to another medicinal 

product of the same MAH. - Deletion of manufacturing site. NB: This exclusive document has been prepared by IDRAC by 

integrating the seven or eight files released in English by the EMEA into one comprehensive document. Consequently, the 

page numbering is not in sequence, but has been left so that the user can appreciate the reorganisation done by IDRAC. It 

is also enriched by a detailed Table of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on EMTRIVA (emtricitabine): EMEA/H/C/533 Revision 

12 (92977). 





European Union - EMA EPAR EMEA/H/C/594 Revision 19: TRUVADA 

(emtricitabine / tenofovir disoproxil) 

Name of the medicinal product: TRUVADA - International Nonproprietary Name: emtricitabine / tenofovir disoproxil - 

Marketing Authorisation Holder: Gilead Sciences Intl Ltd - Pharmaco-therapeutic group - (ATC Code): Antiviral for systemic 

use; antivirals for treatment of HIV infections, combinations - (J05AR03) - Therapeutic indication(s): + TRUVADA is a fixed 

dose combination of emtricitabine and tenofovir disoproxil fumarate. It is indicated in antiretroviral combination therapy for 

the treatment of HIV-1 infected adults. + The demonstration of the benefit of the combination emtricitabine and tenofovir 

disoproxil fumarate in antiretroviral therapy is based solely on studies performed in treatment-naïve patients (see section 

5.1). - Pharmaceutical form: Film-coated tablet - Route of administration: Oral use - Packaging: Bottle Risk Management 

Plan: Yes Last changes since the previous version of this EPAR: Major changes: - Update of Summary of Product 

Characteristics and Package Leaflet. Update of sections 4.4, 4.5 and 4.8 of the SmPC and sections 2 and 4 of the PL with 

safety related information following the update of the Company Core Data Sheet. In addition section 4.8 was fully revised 

according to the SmPC guideline and updated in regard of the adverse reaction’s frequency aiming consistency throughout 

all tenofovir DF-containing products, as requested by the CHMP in October 2008. Minor changes: - Changes to an existing 

pharmacovigilance system as described in the DDPS - Change(s) to a DDPS following the assessment of the same DDPS in 

relation to another medicinal product of the same MAH. NB: This exclusive document has been prepared by IDRAC by 

integrating the seven or eight files released in English by the EMEA into one comprehensive document. Consequently, the 

page numbering is not in sequence, but has been left so that the user can appreciate the reorganisation done by IDRAC. It

is also enriched by a detailed Table of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on TRUVADA (emtricitabine / tenofovir disoproxil): 






European Union - EMA EPAR EMEA/H/C/762 Revision 8: XELEVIA (sitagliptin) 

Name of the medicinal product: XELEVIA - International Nonproprietary Name: sitagliptin - Marketing Authorisation Holder: 

Merck Sharp & Dohme Ltd - Pharmaco-therapeutic group - (ATC Code): Drugs used in diabetes, Dipeptidyl peptidase 4 

(DPP-4) inhibitors - (A10BH01) - Therapeutic indication: For patients with type 2 diabetes mellitus, XELEVIA is indicated to 

improve glycaemic control: + As monotherapy: ++ in patients inadequately controlled by diet and exercise alone and for 

whom metformin is inappropriate due to contraindications or intolerance. + As dual oral therapy in combination with: ++ 

metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. ++ a sulphonylurea 

when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and 

when metformin is inappropriate due to contraindications or intolerance. ++ a PPARγ agonist (i.e. a thiazolidinedione) when 

use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate 

glycaemic control. + As triple oral therapy in combination with: ++ a sulphonylurea and metformin when diet and exercise 

plus dual therapy with these agents do not provide adequate glycaemic control. ++ a PPARγ agonist and metformin when 

use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide 

adequate glycaemic control. + XELEVIA is also indicated as add-on to insulin (with or without metformin) when diet and 

exercise plus stable dosage of insulin do not provide adequate glycaemic control. - Pharmaceutical form: Film-coated tablets 

- Route of administration: Oral use - Packaging: + Blister + Perforated unit dose blister Risk Management Plan: Yes Last 

changes since the previous version of this EPAR: Major changes: - Variations related to significant modifications of the 

Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data. Minor 

changes: - There have been no minor changes. NB: This exclusive document has been prepared by IDRAC by integrating 

the seven or eight files released in English by the EMEA into one comprehensive document. Consequently, the page 

numbering is not in sequence, but has been left so that the user can appreciate the reorganisation done by IDRAC. It is also 

enriched by a detailed Table of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on XELEVIA (sitagliptin): EMEA/H/C/762 Revision 7 

(111927). 





European Union - EMA EPAR EMEA/H/C/777 Revision 5: ADENURIC (febuxostat) 

Name of the medicinal product: ADENURIC - International Nonproprietary Name: febuxostat - Marketing Authorisation 

Holder: Menarini International O. L. S.A. - Pharmaco-therapeutic group - (ATC Code): Preparations inhibiting uric acid 

production - (M04AA03) - Therapeutic indication(s): Treatment of chronic hyperuricaemia in conditions where urate 

deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). - Pharmaceutical form: 

Film-coated tablet - Route of administration: Oral use - Packaging: Blister Risk Management Plan: Yes Last changes since 

the previous version of this EPAR: Major changes: - Changes (Safety/Efficacy) to Human and Veterinary Medicinal Products 

- Other variation. Minor changes: - There have been no minor changes. NB: This exclusive document has been prepared by 

IDRAC by integrating the seven or eight files released in English by the EMEA into one comprehensive document. 



Comment: This document replaces the previous version of the EPAR on ADENURIC (febuxostat): EMEA/H/C/777 Revision 4 

(108309). 





European Union - EMA EPAR EMEA/H/C/910 Revision 6: TESAVEL (sitagliptin) 

Name of the medicinal product: TESAVEL - International Nonproprietary Name: sitagliptin - Marketing Authorisation Holder: 

Merck Sharp & Dohme Ltd - Pharmaco-therapeutic group - (ATC Code): Drugs used in diabetes, Dipeptidyl peptidase 4 

(DPP-4 ) inhibitors - (A10BH01) - Therapeutic indication: For patients with type 2 diabetes mellitus, TESAVEL is indicated to 

improve glycaemic control: + As monotherapy: ++ in patients inadequately controlled by diet and exercise alone and for 

whom metformin is inappropriate due to contraindications or intolerance. + As dual oral therapy in combination with: ++ 

metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. ++ a sulphonylurea 

when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and 

when metformin is inappropriate due to contraindications or intolerance. ++ a peroxisome proliferator-activated receptor 

gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise

plus the PPARγ agonist alone do not provide adequate glycaemic control. + As triple oral therapy in combination with: ++ a 

sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate 

glycaemic control. ++ a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and 

exercise plus dual therapy with these agents do not provide adequate glycaemic control. + TESAVEL is also indicated as 

add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate 

glycaemic control. - Pharmaceutical form: Film-coated tablet - Route of administration: Oral use - Packaging: + Blister + 

Perforated unit dose blister Risk Management Plan: Yes Last changes since the previous version of this EPAR: Major 

changes: - Variations related to significant modifications of the Summary of Product Characteristics due in particular to new 

quality, pre-clinical, clinical or pharmacovigilance data. Minor changes: - Administrative change - Change in the name 

and/or address of a manufacturer or supplier of the active substance, starting material, reagent or intermediate used in the 

manufacture of the active substance NB: This exclusive document has been prepared by IDRAC by integrating the seven or 




Comment: This document replaces the previous version of the EPAR on TESAVEL (sitagliptin): EMEA/H/C/910 Revision 5 

(98898). 





European Union - EMA EPAR EMEA/H/C/943 Revision 3: KUVAN (sapropterin 

dihydrochloride) 

Name of the medicinal product: KUVAN - International Nonproprietary Name: sapropterin dihydrochloride - Marketing 

Authorisation Holder: Merck KGaA - Pharmaco-therapeutic group - (ATC Code): Various alimentary tract and metabolism 

products - (A16AX07) - Therapeutic indication(s): + KUVAN is indicated for the treatment of hyperphenylalaninaemia (HPA) 

in adult and paediatric patients of 4 years of age and over with phenylketonuria (PKU) who have been shown to be 

responsive to such treatment (see section 4.2). + KUVAN is also indicated for the treatment of hyperphenylalaninaemia 

(HPA) in adult and paediatric patients with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to 

such treatment (see section 4.2). - Pharmaceutical form: Soluble tablet - Route of administration: Oral use - Packaging: 

bottle Orphan medicinal product designation date : 08 June 2004 Risk Management Plan: Yes Last changes since the 

previous version of this EPAR: Major changes: - There have been no major changes. Minor changes: - Stability of FP – 

Extension of the shelf life of the finished product - As packaged for sale (supported by real time data). NB: This exclusive 




Comment: This document replaces the previous version of the EPAR on KUVAN (sapropterin dihydrochloride): 






European Union - EMA EPAR EMEA/H/C/987 Revision 2: EXALIEF 

(eslicarbazepine acetate) 

Name of the medicinal product: EXALIEF - International Nonproprietary Name: eslicarbazepine acetate - Marketing 

Authorisation Holder: BIAL - Portela & Ca S.A. - Pharmaco-therapeutic group - (ATC Code): Antiepileptics, Carboxamide 

derivatives - (N03AF04) - Therapeutic indication: EXALIEF is indicated as adjunctive therapy in adults with partial- onset 

seizures with or without secondary generalisation. - Pharmaceutical form: Tablet - Route of administration: Oral use - 

Packaging: + Blister + Bottle Risk Management Plan: Yes Last changes since the previous version of this EPAR: Major 

changes: - There have been no major changes. Minor changes: - Change in re-test period of the active substance - Change 

in name and/or address of a manuf. of the active substance (no Ph. Eur. cert. avail.) - Change in manuf. of active substance 

without Ph. Eur. certificate - change in manuf. site - Change in test proc. for active substance - other changes 

(replacement/addition) - Change in manuf. of active substance without Ph. Eur. certificate - new manufacturer - Change in 

test proc. for active substance - other changes (replacement/addition) - Change in manuf. of active substance without Ph. 

Eur. certificate - change in manuf. site - Change in test proc. for active substance - minor change NB: This exclusive 




Comment: This document replaces the previous version of the EPAR on EXALIEF (eslicarbazepine acetate): EMEA/H/C/987 

Revision 1 (91750). 




Language : English

European Union - EMA EPAR EMEA/H/C/988 Revision 2: ZEBINIX 

(eslicarbazepine acetate) 

Name of the medicinal product: ZEBINIX - International Nonproprietary Name: eslicarbazepine acetate - Marketing 

Authorisation Holder: BIAL - Portela & Ca S.A - Pharmaco-therapeutic group - (ATC Code): Antiepileptics, Carboxamide 

derivatives - (N03AF04) - Therapeutic indication: ZEBINIX is indicated as adjunctive therapy in adults with partial- onset 

seizures with or without secondary generalisation. - Pharmaceutical form: Tablet - Route of administration: Oral use - 

Packaging: + Blister + Bottle Risk Management Plan: Yes Last changes since the previous version of this EPAR: Major 

changes: - There have been no major changes. Minor changes: - Minor change in labelling or package leaflet not connected 

with the SPC (Art. 61.3 Notification) - Change in re-test period of the active substance - Change in name and/or address of 

a manuf. of the active substance (no Ph. Eur. cert. avail.) - Change in test proc. for active substance - other changes 

(replacement/addition) - Change in manuf. of active substance without Ph. Eur. certificate - change in manuf. site - Change 

in manuf. of active substance without Ph. Eur. certificate - change in manuf. site - Change in manuf. of active substance 

without Ph. Eur. certificate - new manufacturer - Change in test proc. for active substance - other changes 

(replacement/addition) NB: This exclusive document has been prepared by IDRAC by integrating the seven or eight files 

released in English by the EMEA into one comprehensive document. Consequently, the page numbering is not in sequence, 

but has been left so that the user can appreciate the reorganisation done by IDRAC. It is also enriched by a detailed Table 

of Contents provided in the left frame. 

Comment: This document replaces the previous version of the EPAR on ZEBINIX (eslicarbazepine acetate): EMEA/H/C/988 






European Union - EMEA EPAR EMEA/H/C/000710 Revision 6: FOCETRIA 

(pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)) 

Name of the medicinal product: FOCETRIA - International Nonproprietary Name: pandemic influenza vaccine (surface 

antigen, inactivated, adjuvanted) - Marketing Authorisation Holder: Novartis Vaccines and Diagnostics S.r.l. - Pharmacotherapeutic 

group - (ATC Code): Influenza vaccine - (J07BB02) - Therapeutic indication: + Prophylaxis of influenza in an 

officially declared pandemic situation (see sections 4.2 and 5.1). + Pandemic influenza vaccine should be used in 

accordance with Official Guidance. - Pharmaceutical form: Suspension for injection - Route of administration: Intramuscular 

use - Packaging: + Pre-filled syringe (glass) + Vial (glass) Risk Management Plan: Yes Last changes since the previous 

version of this EPAR: Major changes: - Switch from conditional to full Marketing Authorisation - Variations related to 

significant modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or 

pharmacovigilance data Minor changes: - Change in the manufacturer of AS or of a starting material/reagent/intermediate 

for AS - changes to quality control testing arrangements for the active substancereplacement or addition of a site where 

batch control/testing takes place To update the relevant section 3.2.S.2.1 with regards to a contact manufacturer NB: This 

exclusive document has been prepared by IDRAC by integrating the seven or eight files released in English by the EMEA into 

one comprehensive document. Consequently, the page numbering is not in sequence, but has been left so that the user can 


Comment: This document replaces the previous version of the EPAR on FOCETRIA (pandemic influenza vaccine (surface 

antigen, inactivated, adjuvanted)): EMEA/H/C/710 Revision 5 (111184). 





European Union - EMEA EPAR EMEA/H/C/1053 Revision 2: CLOPIDOGREL TEVA 

(clopidogrel) 

Name of the medicinal product: CLOPIDOGREL TEVA - International Nonproprietary Name: clopidogrel - Marketing 

Authorisation Holder: Teva Pharma B.V. - Pharmaco-therapeutic group - (ATC Code): Platelet aggregation inhibitors excl. 

heparin - (B01AC-04) - Therapeutic indication: + Clopidogrel is indicated in adults for the prevention of atherothrombotic 

events in: ++ Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke 

(from 7 days until less than 6 months) or established peripheral arterial disease. ++ Patients suffering from acute coronary 

syndrome: +++ Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial 

infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination 

with acetylsalicylic acid (ASA). +++ ST segment elevation acute myocardial infarction, in combination with ASA in medically 

treated patients eligible for thrombolytic therapy. + For further information please refer to section 5.1. - Pharmaceutical 

form: Film-coated tablet - Route of administration: Oral use - Packaging: + Blister + Bottle Risk Management Plan: No Last 

changes since the previous version of this EPAR: Major changes: - There have been no major changes. Minor changes: - 

Change in the SPC, Labelling or PL of a generic/hybrid/biosimilar products following assessment of the same change for the 

reference product - Implementation of change(s) for which NO new additional data are submitted by the MAH - Container 

closure system of the active substance - Other variation To add a desiccant as an intermediate packaging component for the

active substance. - Replacement/add. of manufacturing site: Secondary packaging site NB: This exclusive document has 

been prepared by IDRAC by integrating the seven or eight files released in English by the EMEA into one comprehensive 



Comment: This document replaces the previous version of the EPAR on CLOPIDOGREL TEVA (clopidogrel): EMEA/H/C/1053 






European Union - EMEA EPAR EMEA/H/C/582 Revision 17: AVASTIN 

(bevacizumab) 

Name of the medicinal product: AVASTIN - International Nonproprietary Name: bevacizumab - Marketing Authorisation 

Holder: Roche Registration Limited - Pharmaco-therapeutic group - (ATC Code): Monoclonal antibody - (L01X C07) - 

Therapeutic indication(s): + AVASTIN (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated 

for treatment of patients with metastatic carcinoma of the colon or rectum. + AVASTIN in combination with paclitaxel or 

docetaxel is indicated for first-line treatment of patients with metastatic breast cancer. For further information as to HER2 

status, please refer to section 5.1. + AVASTIN, in addition to platinum-based chemotherapy, is indicated for first-line 

treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than 

predominantly squamous cell histology. + AVASTIN in combination with interferon alfa-2a is indicated for first line treatment 

of patients with advanced and/or metastatic renal cell cancer. - Pharmaceutical form: Concentrate for solution for infusion - 

Route of administration: Intravenous use - Packaging: Vial Risk Management Plan: Yes Last changes since the previous 

version of this EPAR: Major changes: - Variations related to significant modifications of the Summary of Product 

Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data Update of section 4.4 of the 

SmPC to include a warning on adverse reactions reported following unapproved intravitreal use with Avastin. This proposed 

update results from a safety review conducted by the Marketing Authorisation Holder (MAH). The Package Leaflet has been 

updated accordingly. Based on a safety review of ocular events after off-label intravitreal/intraocular Avastin use, performed 

by the MAH it has been concluded by the CHMP that information on eye disorders from unapproved intravitreal use should 

be included as a safety warning in section 4.4 of the SmPC. Therefore the SmPC has been updated to include a warning that 

infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitritis, retinal detachment, 

retinal pigment epithelial tear, intraocular pressure increased, intraocular haemorrhage such as vitreous haemorrhage or 

retinal haemorrhage and conjunctival haemorrhage have been reported following unapproved intravitreal use of Avastin. 

The PL has been updated accordingly. Minor changes: - There have been no minor changes. NB: This exclusive document 

has been prepared by IDRAC by integrating the seven or eight files released in English by the EMEA into one comprehensive 



Comment: This document replaces the previous version of the EPAR on AVASTIN (bevacizumab): EMEA/H/C/582 Revision 

16 (112071). 





European Union - Texts Adopted at the Sitting of Wednesday 22-Sep-2010 

(P7_TA-PROV(2010)0331) 

At the sitting of Thursday 22-Sep-2010, the European Parliament adopts its position at the first reading on the proposal for 

a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products 

for human use, Regulation (EC) No 726/2004 (44203) laying down Community procedures for the authorisation and 

supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency 

(COM(2008)0664 – C6-0515/2008 – 2008/0257(COD)). This document is the provisional edition. 

Comment: Please see also: - "Opinion of the European Economic and Social Committee (EESC) on the Proposal for a 

Regulation of the European Parliament and of the Council, Amending, as regards Pharmacovigilance of Medicinal Products 

for Human Use, Regulation (EC) No 726/2004 laying down Community procedures for the Authorisation and Supervision of 

Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency, COM(2008) 664 final – 

2008/0257 (COD), 16-Dec-2009" (92822) - "Proposal COM(2008) 664 final: for a Regulation of the European Parliament 

and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 

726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and 

veterinary use and establishing a European Medicines Agency, 10-Dec 2008" (87800). 


Type of text : EU Parliament Report, Report 


Language : English

European Union - Texts Adopted at the Sitting of Wednesday 22-Sep-2010 

(P7_TA-PROV(2010)0332) 

At the sitting of Thursday 22-Sep-2010, the European Parliament adopts its position at the first reading on the proposal for 

a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC 

on the Community code relating to medicinal products for human use (COM(2008)0665 – C6-0514/2008 – 

2008/0260(COD)). This document is the provisional edition. 

Comment: Please see also: - "Proposal COM(2008) 665 final: for a Directive of the European Parliament and of the Council 

amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for 

human use, 10-Dec-2008" (87797). - "Opinion of the European Economic and Social Committee (EESC) on the Proposal for 

a Directive of the European Parliament and of the Council, Amending, as regards pharmacovigilance, Directive 2001/83/EC 

on the Community Code Relating to Medicinal Products for Human Use COM(2008) 665 final – 2008/0260 (COD), 16-Dec- 

2009" (92828). 


Type of text : EU Parliament Report, Report 



European Union - CMDh Form: Reference Member State Day 70 Preliminary 

Assessment Report (Decentralised Procedure), Sep-2010 

This Form is intended to be used to submit a quality critical assessment report at day 70 of the decentralised procedure. 

This Form is available in a ready-to-use format. 

Document date : Sep-2010 

Type of text : Form 



European Union - EMA Form: Annual Report on Deferral Granted in the Paediatric 

Investigation Plan, Version 1.0.1, 01-Oct-2010 

This form is intended to be used to provide an annual report on deferral granted in the paediatric investigation plan. This 

form is available in the ready-to-use format. 





European Union - Electronic Form for All Non-Clinical and Clinical Studies to Be 

Included in the PIP, Version 1.1.2, 01-Oct-2010 

This form has been prepared by the European Medicines Agency to submit all non-clinical and clinical studies to be included 

for a PIP at the time of application or for modification of an agreed PIP. 

Comment: This document should be read in conjonction with: "EMA Form: Paediatric Investigation Plan Application and 

Request for Waiver, Version 2.2.3, Jan-2010" (102401). 





European Union - Form: Recommendation of the CMDh on the Classification of an 

Unforeseen Variation to the Terms of the Marketing Authorisation, Updated Sep- 

2010 

This Form is to be used by stakeholders to request CMD(h) for nationally authorised products to deliver a recommendation 

on classification of an unforeseen variation. The request should include a justification of why the variation is considered to 

be unclassified in the variation guideline, together with a proposed classification. This Form is available in the ready-to-use 

format. 



Regulatory version : Final, Revision 


European Union - Template for Notification of Change of the PIP/Waiver 

Applicant/Addressee, Oct-2010 

This form is available in ready-to-use format. It is to be used for any change in the PIP/waiver applicant/addresse.





European Union - Template to Change Applicant Name or Details, Oct-2010 

This form is available in ready-to-use format. It is to be used for any change of contact details for a PIP or waiver 

application. 





European Union - CMD(h)/144/2000/Rev 22: Contact Points for Advice on 

Mutual Recognition and Decentralised Procedures, Updated Aug-2010 

This list is provided to assist pharmaceutical companies in identifying a contact point for advice on the Mutual Recognition or 

Decentralised Procedures in each Member State. The individuals listed should only be approached for general questions 

regarding the MRP or DCP and not for a particular application. 

Document date : Aug-2010 

Type of text : List 



European Union - CMD(h): Tracking Table for Information on Applications 

Referred to the CMD(h) in Accordance with Article 29(1) of Directive 

2001/83/EC, Updated Sep-2010 

This document provides information regarding 60-day referral procedures, in accordance with Article 29(1) of Directive 

2001/83/EC (37421), submitted to the CMD(h) on 2010, 2009, 2008 and 2006 per type of procedure (MRP vs DCP), per 

type of product, per legal basis, per grounds and per outcome. 





European Union - CMDh/014/2008 Rev.11: List of the Active Substances 

Included in the Worksharing Procedure according to Article 45 of the Paediatric 

Regulation, Updated Sep-2010 

This document provides the list of substances that have been included in the first, second, third, fourth, fifth, sixth and 

seventh waves of the worksharing, according to Article 45 of the Paediatric Regulation (63088). 





European Union - Cumulative Index of PhVWP Monthly Reports, Oct-2010 

This document provides the list of PhVWP monthly reports in alphabetical order of topic titles with their corresponding issue 

numbers. 





European Union - Tracking Table for Information on Applications referred to the 

CMD(h) in accordance with Article 30(2) of Directive 2001/83/EC - 

Harmonisation of SPCs, Updated Sep-2010 

This document provides the list of products for SPC harmonisation, in accordance with Articles 30(2) of Directive 

2001/83/EC, as amended (37421). 




Language : English

European Union - EMA/476864/2010 - P/163/2010: Decision on the Application 

for a Product Specific Waiver for amlodipine besylate / valsartan, 27-Aug-2010. 

The Paediatric Committee has given a positive opinion for granting a waiver for the active substances amlodipine besylate / 

valsartan. - Applicant: Krka, d.d., Novo mesto. - Condition: Hypertension. - Pharmaceutical form: Film-coated tablets. - 

Route of administration: Oral use. 


Type of text : Opinion, PDCO Opinion 




for a Product Specific Waiver for perindopril erbumine / amlodipine besylate, 27- 

Aug-2010 

The Paediatric Committee has given a positive opinion for granting a waiver for the active substances perindopril erbumine / 

amlodipine besylate. - Applicant: Krka, d.d., Novo mesto. - Condition: Hypertension. - Pharmaceutical form: Tablet. - Route 

of administration: Oral use. 






for Agreement of a Paediatric Investigation Plan for CORLENTOR (ivabradine 

hydrochloride), 27-Aug-2010. 

The Paediatric Committee has given a positive opinion for a request for agreement of Paediatric Investigation Plan for the 

medicinal product CORLENTOR (ivabradine hydrochloride). - Applicant: Les Laboratoires Servier. - Conditions: + Coronary 

artery disease + Angina pectoris + Chronic heart failure + Reduction of heart rate during Multislice Computed Tomography 

Coronary Angiography (MSCT CA) - Pharmaceutical forms: + Film-coated tablet + Solution for injection + Oral solution - 

Routes of administration: + Intravenous use + Oral use. More detailed information regarding the Paediatric Investigation 

Plan (PIP): - Proposed PIP indication: Treatment of chronic heart failure. - Age subset: From 6 months to less than 18 years 

of age. - Proposed PIP indication: Reduction of heart rate during Multislice Computed Tomography Coronary Angiography 

(MSCT CA). - Age subset: From 2 to less than 18 years of age. - Date of completion of the PIP: By September 2013. - 

Deferral: Yes 






for Agreement of a Paediatric Investigation Plan for PROCORALAN (ivabradine 

hydrochloride), 27-Aug-2010. 


medicinal product PROCORALAN (ivabradine hydrochloride). - Applicant: Les Laboratoires Servier. - Conditions: + Coronary 

artery disease + Angina pectoris + Chronic heart failure + Reduction of heart rate during Multislice Computed Tomography 

Coronary Angiography (MSCT CA). - Pharmaceutical forms: + Film-coated tablet + Solution for injection + Oral solution - 

Route of administration: + Intravenous use + Oral use More detailed information regarding the Paediatric Investigation Plan 

(PIP): - Proposed PIP indication: Treatment of chronic heart failure. - Age subset: From 6 months to less than 18 years of 

age. - Proposed PIP indication: Reduction of heart rate during Multislice Computed Tomography Coronary Angiography 

(MSCT CA). - Age subset: From 2 to less than 18 years of age. - Date of completion of the PIP: By September 2013. - 

Deferral: Yes. 






for a Product Specific Waiver for MICARDISPLUS (telmisartan / 

hydrochlorothiazide), 27-Aug-2010. 

The Paediatric Committee has given a positive opinion for granting a waiver for the medicinal product MICARDISPLUS 

(telmisartan / hydrochlorothiazide). - Applicant: Boehringer Ingelheim International GmbH. - Condition: Hypertension. -

Pharmaceutical form: Tablet. - Route of administration: Oral use. 






for Agreement of a Paediatric Investigation Plan for tenofovir disoproxil 

fumarate / emtricitabine / rilpivirine hydrochloride, 06-Aug-2010. 


active substances tenofovir disoproxil fumarate / emtricitabine / rilpivirine hydrochloride. - Applicant: Gilead Sciences 

International Limited. - Condition: Treatment of human immunodeficiency virus (HIV-1) infection. - Pharmaceutical forms: 

+ Film-coated tablet + Age-appropriate formulation for oral use - Route of administration: Oral use. More detailed 

information regarding the Paediatric Investigation Plan (PIP): - Proposed PIP indication: Treatment of human 

immunodeficiency virus (HIV-1) infection. - Age subset: From 6 to less than 18 years of age. - Date of completion of the 

PIP: By September 2017. - Deferral: Yes 






for Agreement of a Paediatric Investigation Plan for BARACLUDE (entecavir), 20- 

Aug-2010. 


medicinal product BARACLUDE (entecavir). - Applicant: Bristol-Myers Squibb Pharma EEIG. - Condition: Treatment of 

chronic hepatitis B. - Pharmaceutical forms: + Film-coated tablet + Oral solution - Route of administration: Oral use. More 

detailed information regarding the Paediatric Investigation Plan (PIP): - Proposed PIP indication: + Treatment of chronic 

hepatitis B virus infection in: ++ subjects with HBeAg positive and negative compensated liver disease ++ subjects with 

decompensated liver disease ++ subjects with lamivudine refractory chronic hepatitis B. - Age subset: From 2 to less than 

18 years of age. - Date of completion of the PIP: By December 2017. - Deferral: Yes 






for Agreement of a Paediatric Investigation Plan for INOVELON (rufinamide), 27- 

Aug-2010. 


medicinal product INOVELON (rufinamide). - Applicant: Eisai Ltd. - Condition: Treatment of Lennox-Gastaut Syndrome. - 

Pharmaceutical form: Oral suspension, tablets. - Route of administration: Oral use. More detailed information regarding the 

Paediatric Investigation Plan (PIP): - Proposed PIP indication: Adjunctive therapy in the treatment of seizures associated 

with Lennox-Gastaut syndrome. - Age subset: From 1 to less than 4 years of age. - Date of completion of the PIP: By 

September 2017. - Deferral: Yes 





European Union - EMA/525486/2010 - P/154/2010: Decision on the Acceptance 

of a Modification of an Agreed Paediatric Investigation Plan for boceprevir, 27- 

Aug-2010. 

The Paediatric Committee has given a positive opinion for a request for a modification of the Paediatric Investigation Plan for 

the active substance boceprevir. - Applicant: Merck Sharp & Dohme Ltd. - Condition: Chronic Hepatitis C. - Pharmaceutical 

forms: + Granules + Hard capsules - Route of administration: Oral use More detailed information regarding the Paediatric 

Investigation Plan (PIP): - Proposed PIP indication: Treatment of children and adolescents from 3 years to less than 18 

years of age with genotype 1 chronic HCV infection and without liver decompensation. - Age subset: From 3 to less than 18 

years of age. - Date of completion of the PIP: By Oct 2016 - Deferral: Yes 

Comment: This document replaces the previous version: "EMA/282478/2010 - P/97/2010: Decision on the Application for 

Agreement of a Paediatric Investigation Plan for boceprevir, 04-Jun-2010 (111149). 

Document date : 27-Aug-2010





for Agreement of a Paediatric Investigation Plan for clindamycin phosphate / 

tretinoin, 27-Aug-2010. 


active substances clindamycin phosphate / tretinoin. - Applicant: MEDA Pharma GmbH & Co. KG. - Condition: Acne vulgaris. 

- Pharmaceutical form: Gel. - Route of administration: Cutaneous use. More detailed information regarding the Paediatric 

Investigation Plan (PIP): - Proposed PIP indication: Treatment of acne vulgaris. - Age subset: From 12 to less than 18 years 

of age. - Date of completion of the PIP: By March 2005. - Deferral: No 





European Union - CMDh/183/2010: Overview of Timetables 2011 - CMDh 60-Day 

Procedures for MRP/DCP Applications, Aug-2010 

This document provides information for Applicants regarding the possible timetables for the applications referred to the 

CMD(h), in accordance with Article 29(1) of Directive 2001/83/EC, as amended (37421), for the year 2011. 


Type of text : Overview 



European Union - CMD(h)/075/2007/Rev1: Common Grounds for 

Invalidation/Delaying Validation, updated Sep-2010 

This document lists the common grounds for invalidation/delaying validation 





European Union - CMDh Recommendation for classification of unforeseen 

variations according to Article 5 of Commission Regulation (EC) No 1234/2008, 

Updated Sep-2010 

Where a classification for variation cannot be easily determined, Article 5 of Commission Regulation (EC) No 1234/2008 

(87560) enables MAH to request the CMD(h), as far as decentralised authorisations are concerned, to provide a 

recommendation . This table summarises the recommandations given by the CMD(h) on the classification of the variation. 





European Union - CMDh/182/2010: Timetables for Request to CMD(h) for a 

Recommendation on the Classification of an Unforeseen Variation - Article 5 of 

Commission Regulation (EC) No. 1234/2008, Updated Aug-2010 

This document gives timetables for request to CMD(h) for a recommendation on the classification of an unforeseen 

variation. Please also refer to: - CMD(h): Best Practice Guide - Recommendations on Unforeseen Variations 

(CMDh/135/2009 Rev 0), Mar-2009 (90438) - Form: Recommendation of the CMDh on the Classification of an Unforeseen 

Variation to the Terms of the Marketing Authorisation, Mar-2010 (105684) 





European Union - CMDh/132/2009/Rev7: Questions & Answers - List for the 

Submission of Variations According to Commission Regulation (EC) 1234/2008,

Sep-2010 

This document provides a list of questions and answers regarding the submission of variations according to Commission 

Regulation (EC) 1234/2008 (87560). 

Comment: This document replaces the previous version issued in Jul-2010 (111678). 





European Union - CMDh/070/1999/Rev3: Recommendations on Informed 

Consent Applications in Mutual Recognition & Decentralised Procedures, Sep- 

2010 

This document provides information on the recommendations made by the CMD(h) so as to facilitate and harmonise the 

regulatory issues for submission of informed consent applications in the decentralised and mutual recognition procedures. 

This document covers the following points: - Legal framework: Extracts from European legislation - Definition of the 

Reference product and Informed consent applications - Dossier requirement - Situation 

Comment: This document replaces the previous version issued in Jul-2006 (59989). 


Type of text : Recommendation 



European Union - EMA/499025/2010: Annual Report Highlights, 04-Oct-2010 

This document gives the highlights from the European Medicines Agency's annual report for 2009. It covers the following 

topics: - improving the effectiveness and efficiency of the Agency's core activities - consolidating the Agency's international 

strategy in the light of global challenges - strengthening the European medicines network - improving the safey-monitoring 

of medicines - implementing and operating the Advanced Therapies Regulation and other new legislation - fostering 

transparency, communication and the provision of information - contributing to improved availability of medicines 


Type of text : Report 



European Union - EMA/607491/2010: Interim Report on the International API 

Inspection Pilot Programme, 23-Sep-2010 

This document provides information on the interim report on the International API Inspection Pilot Programme. The aim of 

this interim report is to give an update on the completion of the Pilot Programme after 18 months and to verify if what has 

been achieved so far corresponds to the expected deliverables. During the Transatlantic Administrative Simplification 

Workshop in Nov-2007 and the 2nd International Summit in Dec-2007, the idea of setting up a pilot project for Active 

Pharmaceutical Ingredients (API) undertaken by a group of interested regulators, was proposed. This was thought in the 

context of improving international sharing of information and to promote more risk based approaches to inspection 

planning. In addition, such a project would result in building on equivalent API GMP standards and consequently would 

encourage mutual confidence between regulators. The interested parties include a number of EU Member States active in 

the area of inspections of active pharmaceuticals (France, Germany, Ireland, Italy, UK), the European Directorate for the 

Quality of Medicines and Healthcare (EDQM) from the Council of Europe, the US Food and Drug Administration (FDA) and 

the Australian Therapeutic Goods Administration (TGA). A more comprehensive analysis of learnings will be provided in the 

final report. 

Comment: Please see also: "EMEA/INS/GMP/414323/2008: Pilot Project to Rationalise International GMP Inspection 

Activities - Rules of Engagement and Procedures for Participating Authorities (Active Pharmaceutical Ingredients / Active 

Substances), 07-Jan-2009" (88188). 





European Union - EMA/CAT/601590/2010: 19th Committee for Advanced 

Therapy (CAT), Meeting Monthly Report, 16/17-Sep-2010, 21-Sep-2010 

The Committee for Advanced Therapies (CAT) held its 19th meeting on 16/17-Sep-2010. The CAT is a multidisciplinary 

committee in charge of assessing the quality, safety and efficacy of advanced therapy medicinal products all the while 

following scientific developments. The CAT monthly report provides scientific recommendations on the advanced therapy 

classification, organisational matters, and general scientific issues, within the centralised procedure. The report also includes 

an overview of product-related activities based on a summary table of the draft opinions issued by the CAT in the current

year and a list of adopted guidelines and other public documents. Upcoming meeting: 14/15-Oct-2010 





European Union - EMA/CHMP/PhVWP/589053/2010: Pharmacovigilance 

Working Party (PhVWP) - September 2010 Plenary Meeting, 20/22-Sep-2010 

The CHMP Pharmacovigilance Working Party (PhVWP) held its September plenary meeting on 20/22-Sep-2010. During this 

meeting, three topics on safety concerns were discussed: - Benzydamine – Risk of adverse reactions after incorrect oral 

intake - Lamotrigine – Risk of aseptic meningitis - Tamoxifen – Risk of reduced therapeutic response in patients who are 

poor CYP2D6 metabolisers or use medicines inhibiting CYP2D6 Three topics on guidelines and general matters were also 

discussed: - Election of PhVWP Vice-Chairperson - New legislation for pharmacovigilance in the European Union - 1st EMA 

Scientific Workshop on Nanomedicines on 2-3 September 2010 





European Union - EMA/HMPC/592652/2010: Thirty-Seventh Meeting Report 

15/16-Sep-2010 of the Committee on Herbal Medicinal Products (HMPC), 05- 

Oct-2010 

The Committee on Herbal Medicinal Products met for the thirty-seventh time at the EMA offices on 15/16-Sep-2010. During 

this meeting, reports were established by MLWP, Organisational Matters Drafting Goup and Quality Drafting Group. The 

HMPC welcomed a new committee member and this document also provides a list of final community herbal 

monographs/community list entries and a list of draft community herbal monographs. 





European Union - Heads of Medicines Agencies (HMA) / Telematics 

Implementation Group for Electronic Submission (TIGes): eCTD Implementation 

Survey Report, v5.0, Covering July 2009 to December 2009, Oct-2010 

This document provides information on the eCTD Implementation Survey Report, covering the period from July to December 

2009. Its goal is to follow the evolution of preparedness and readiness of the Network for paperless operation and the 

progress towards the target of 2009. This document is the fifth version and contains the following sections: - the 

methodology undertaken for this survey - the outcome of the questionnaire (divided between the readiness for acceptance 

of paperless applications of marketing authorisations and statistics of applications for marketing authorisation) - the 

conclusions of the questionnaire survey - Annex 1: the EU Ectd Implementation Questionnaire - Annex 2: a list of published 

guidance documents - Annex 3: a list of electronic submission contact points 





European Union - Heads of Medicines Agencies (HMA): Paediatric Public 

Assessment Report on ACTONEL / OPTINATE (risedronate sodium), 14-Sep-2010 

Name of medicinal product: ACTONEL / OPTINATE Active substance: risedronate sodium Pharmaceutical form: - Film-coated 

tablets 5mg,30mg,35mg and 75mg risedronate - Film-coated tablets 35 mg risedronate + 500g calcium - Film-coated 

tablets 35 mg risedronate + sachet 1000 mg calcium/880 IU vitamin D3 - Film-coated tablets 35 mg risedronate + 500 mg 

calcium/400 IU vitamin D3 Marketing Authorisation Holder: - Procter & Gamble Pharmaceuticals - Sanofi-aventis - Aventis 

Pharma - Gruppo Lepetit SRL Rapporteur: UK 






Assessment Report on ASRMA SA / ARVEKAP / DECAPEPTYL DEPOT / 

GONAPEPTYL (triptorelin), 17-Feb-2010

Name of medicinal product: ASRMA SA / ARVEKAP / DECAPEPTYL DEPOT / GONAPEPTYL Active substance: triptorelin 

Pharmaceutical forms: - Powder and solvent for suspension for injection 3.75mg - Powder and solvent for suspension for 

injection 11.25mg Therapeutic indication: central precocious puberty Marketing Authorisation Holders: - Ferring BV - Ferring 

(Ferring AB, Ferring Laaket Oy, Ferring AS, Ferring GmbH) - Ferring Arzneimittel GmbH - Ferring AS Slovak Republic - 

FGerring SAS - Ferrring Legemidier - Beaufort Ipsen International - Ipsen NV - Ipsen Pharma - Ipsen E.P.E. - Ipsen Pharma 

SA - Ipsen SPA - Ipsen Portugal Produtos Farmaceuticos SA - Beaufour Ipsen Pharma - Ipsen LTD - Ipsen Pharmaceuticals 

LTD Rapporteur: Malta 

Document date : 17-Feb-2010 





Assessment Report on DITROPAN / DRIDASE / CYSTRIN (oxybutynin 

hydrochloride), 15-Sep-2010 

Name of medicinal product: DITROPAN / DRIDASE / CYSTRIN Active substance: oxybutynin hydrochloride Pharmaceutical 

form: ORAL FORMULATIONS: - 2.5 mg, 3mg, 5mg and 10mg tablets (film-coated or prolonged release tablets) - 5mg/5ml 

syrup - 2.5mg/5ml oral solution Therapeutic indication: - Neurogenic bladder disorders - Enuresis Marketing Authorisation 

Holder: - Sanofi-Aventis - Aventis Pharma LTD UK - Mylan AB Rapporteur: UK 






Assessment Report on FAMVIR (famciclovir), 20-Jul-2010 

Name of medicinal product: FAMVIR Active substance: famciclovir Pharmaceutical form: Film-coated tablets, 125, 250 and 

500 mg Marketing Authorisation Holder: Novartis Pharma GmbH Rapporteur: Germany 

Document date : 20-Jul-2010 





Assessment Report on STRUCTUM (chondroitin sulfate), 14-Sep-2010 

Name of medicinal product: STRUCTUM Active substance: chondroitin sulfate Pharmaceutical form: Hard capsules 250mg, 

500mg Therapeutic indication: Symptomatic treatment of osteoarthritis Marketing Authorisation Holder: Pierre Fabre 

Medicament Rapporteur: UK 





European Union - SOP/H/3008: SOP on Publication of documents, new 

information, modifications & updates on EV Website, 28-Sep-2010. 

This SOP is intended to explain publication of documents, new information, modifications and updates on EV Website. 

Changes since last revision: - SOP/H/3008 updated to reflect the new organisatinal names in the Agency, minor re-wording 

of Step 7 and change in procedure in Step 10. 

Comment: This version replaces the version issued on 07-Jan-2009 (88138). 


Type of text : SOP 



European Union - SOP/H/3289: SOP on Handling of request for data analysis 

clarifying critical aspects of medicines benefit/risk profile, 13-Sep-2010 

This SOP is intended to Handling of request for data analysis clarifying critical aspects of medicines benefit/risk profile. 




Language : English

European Union - WIN/H/3134: WIN on CHMP Agenda & Time schedule, 16-Sep- 

2010 

This WIN is intended to CHMP secretariat. Changes since last revision: - Updated to reflect the new organisational structure 

in the Agency. 

Comment: This version replaces the version issued on 15-Dec-2008 (87708). 





European Union - WIN/H/3135: WIN on CHMP related activities – Meeting 

organisation and Committee membership, 16-Sep-2010. 

This WIN is intended to explain the CHMP related activities – Meeting organisation and Committee membership. This WIN 

applies to CHMP Secretariat. Changes since last revision: - Updated to reflect new organisational names in the Agency. 






European Union - WIN/H/3234: WIN on CHMP Monthly Report, 16-Sep-2010. 

This WIN is intended to prepare CHMP Monthly Reports. Changes since the last revision: - Updated to reflect the new 

organisational structure in the Agency. 






European Union - WIN/H/3235: WIN on CHMP Table of Decisions & Minutes, 16- 

Sep-2010. 

This WIN is intended to prepare CHMP Table of Decisions and CHMP Minutes. Changes since last revision: - Updated to 

reflect the new organisational structure in the Agency. 






European Union - WIN/H/3262: WIN on CHMP Activities - Preparation of 

Document Lists & Post Mailing, 16-Sep-2010. 

This WIN is intended to explain the CHMP Activities - Preparation of Document Lists and Post Mailing. Changes since last 

revision: - Changes to reflect new organisational structure. Removal of requirement for hard copy paper archive. 






European Union - WIN/H/3266: WIN on Performing Data Analysis of 

EudraVigilance Data using EVDAS, 30-Aug-2010 

This WIN is intended to Data Collection and Management Section in the Pharmacovigilance and Risk Management Sector 

Changes since last revision: - New WIN. 





European Union - WIN/H/3277: WIN on Identification of Active Substances to 

be entered in EudraVigilance Medicinal Products Dictionary (EVMPD), 23-Sep- 

2010.

This WIN is intended to explain the Identification of Active Substances to be entered in the EudraVigilance Medicinal 

Products Dictionary (EVMPD). This WIN applies to PharmacoVigilance and Risk Management Sector. Changes since last 

revision: - Updated to reflect new organisational names in the Agency. 

Comment: This version replaces the version issued on 23-Jun-2009 (92873). 





European Union - WIN/H/3278: WIN on Creation of Scientific Products in the 

EudraVigilance Medicinal Products Dictionary (EVMPD), 23-Sep-2010 

This WIN is intended to PharmacoVigilance and Risk Management Sector. Changes since last revision: - Updated to reflect 

the new organisational names in the Agency. 

Comment: This version replaces the version issued on 23-Jun-2009 (92877). 





European Union - WIN/H/3290: WIN on Validation and interpretation of data 

analysis conducted on EudraVigilance, 13-Sep-10 

This WIN is intended to Pharmacovigilance and Risk Management Sector. Changes since the last revision: - Updated to 

reflect changes made to SOP/H/3289 

Comment: This version replaces the version issued on 26-Mar-2010 (105936). 





European Union - WIN/H/3302: WIN on EudraVigilance Medicinal Product 

Dictionary: Population with Approved Substances - type Vaccines, 20-Sep-2010 

This WIN is intended to Staff members in the Pharmacovigilance and Risk Management Sector responsible for population of 

the EVMPD with Approved Substances. Changes since last revision: - Updated to reflect the new organisational names in the 

Agency. 

Comment: This version replaces the version issued on 07-Jul-2009 (93324). 





European Union - EMA Workshop on Paediatric Formulations for Assessors in 

National Regulatory Agencies held on 31-May-2010, 05-Oct-2010 

The Workshop on Paediatric Formulations for Assessors in National Regulatory Agencies was held at the EMA on 31-May- 

2010. This document provides the following information: - Agenda - Report (including a list of participants) - Presentations: 

Paediatric regulation: an update on submissions of paediatric investigation plans Introduction to the work of the PDCO 

Formulation Working Group FDA, EuPFI, WHO Collaborations Article 8 – Paediatric Regulation: Interpretation of 

pharmaceutical form Paediatric formulations: The clinical perspective Formulations for clinical trials in children: Possibilities 

and pitfalls? Preservatives: Are they safe? Excipients: Safe or not safe? Poorly water soluble substances: challenges, options 

and limitations for children Legislation and available guidance for the evaluation of PIPs (quality): viewpoint from the EMA 

Completion of the development of a formulation: Requirements for compliance check vs. requirements for marketing 

authorisation Assessment of a MAA: Awareness of the PIP recommendation: Generic applications 


Type of text : Workshop Documents 



Finland 

Finland - Information Note: Fimea Expands its Office Network in Turku, 05-Oct- 

2010 

This document informs that Fimea’s new local office is located in Turku Science Park (Kupittaa Pharma City) where Fimea 

has its office and five local employees. 16 employees are currently working at Technopolis Kuopio, which will be Fimea’s

head office by 2014. In addition to this head office in Kuopio, Fimea has its own offices in Helsinki, Turku, Tampere and 

Oulu. 


Type of text : Information Note 


Language : Finnish 

Finland - Information Note: Fimea's Role in the Quality Control of 

Biopharmaceutical is Growing, 10-Sep-2010 

This document informs that third of developing new medicinal products belongs to the group of biological medicinal 

products, made from proteins in living cells. This new type of manufacturing methods and the limited shelf-life increase the 

risks of safety and quality. Fimea's Medicine Control Laboratory has implemented the latest research methods in the quality 

control of these products. The agency is now able to provide the quality and efficacy of medicinal products in vitro chemical, 

pharmaceutical and microbiological methods, but also by biological methods. 




Language : Finnish 

France 

France - Order of 24-Sep-2010: Addendum no. 91 to the Pharmacopoeia 

The modifications of the French pharmacopoeia (10th edition) entitled "Mise à jour 2010" are applicable starting October 

1st, 2010. The monograph, antiseptic preparations, of the French Pharmacopoeia is removed as from October 1st, 2010. 


Type of text : Order 


Language : French 

France - AFSSAPS Press Release (29-Sep-2010): Warning - Confusion Between 

Dosettes in a Two-Month-Old Infant 

The AFSSAPS and the Sanitary Surveillance Institute (Institut de Veille Sanitaire - INVS) have been informed of a case of 

confusion between two dosettes (single dose) of chlorhexidine and physiological saline solution in an infant aged of two 

months. The French Agency wishes to remind that the use of single dose requires a careful reading of the labels before 

administration in order to avoid any risk of confusion between products with different purposes. The AFSSAPS is currently 

conducting a reflection on this type of confusion whose results will develop recommendations on the use of single doses. 




Language : French 

Germany 

Germany - BfArM Letter: Protection from Drug Risks - Stage II - Sibutramine- 

Containing Medicinal Products - 30-Sep-2010 

The BfArM orders the immediate suspension of the MA authorization of sibutramine-containing medicinal products until 30- 

Sep-2011. This decision implements the final decision of the European Commission (K(2010)5597) that concluded a referral 

procedure under Art. 107 of the Community Code "European Parliament and Council Directive 2001/83" (37421) for 

sibutramine- containing medicinal products, due to safety concerns raised by data from the Sibutramine Cardiovascular 

OUTcomes (SCOUT) study. 


Type of text : BfArM Letter, Letter 



Germany - BfArM Letter: Protection from Drug Risks – Hearing, Stage II - 

Nitrofurantoin-Containing Medicinal Products - 21-Sep-2010 

Due to new ADR reports and publication of suspicious cases of pulmonary fibrosis and liver damage caused by 

nitrofurantoin, the BfArM and the Commission of Medicinal Products for Pediatric Use ("KAJK") initiated in 2009 a review of 

the benefit-risk profile of the authorized and recommended indications of nitrofurantoin with particular regards to its use in 

children and teenagers. This review resulted in the issue of scientific statements regarding the genetic toxicology and the 

clinical safety of nitrofurantoin agreed by the Akdä (“Drug Commission of the German Medical Association”). On the basis of 

the review, the BfArM considers it is necessary to modify the product information of nitrofurantoin-containing medicinal

products. Sections “Dosage” and “Precautions for use” are particularly concerned. The BfArM has set out a four-week period 

as a deadline for concerned manufacturers to take position on the proposed measures intended to protect from risks related 

to nitrofurantoin. For the scientific statements on genetic toxicology and clinical safety of nitrofurantoin-containing medicinal 

products, please refer to: - “BfArM Statement on Genetic Toxicology: Nitrofurantoin for the Prophylaxis of Recidiving Urinary 

Tract Infections ("Last Line Indication") - New Assessment of the Benefit-Risk Profile - Jun-2010 (114143).” - “BfArM 

Statement on Clinical Safety: Nitrofurantoin for the Prophylaxis of Recidiving Urinary Tract Infections ("Last Line Indication") 

- New Assessment of the Benefit-Risk Profile - Jun-2010 (114144)”. 

Comment: This Letter has been published by the BfArM without its distribution list and annexes. 


Type of text : BfArM Letter, Letter 



Germany - Red Hand Letter: QUIXIL/EVICEL Solutions for Fibrin Sealants - 16- 

Aug-2010 

Product Name: QUIXIL/EVICEL Pharmaceutical Form: solutions for fibrin sealants Route of administration: epilesional use 

Marketing Authorization Holder: Omrix Biopharmaceuticals Ltd. This Red Hand letter contains important safety information 

for healthcare professionals about the risk of life-threatening air or gas embolism with the use of spray devices with 

pressure regulator for the administration of QUIXIL/EVICEL solutions for fibrin sealants (human). The product information 

(SmPC) has been updated. It includes the instructions for proper use of fibrin sealants with a spray device in order to avoid 

air or gas embolism. Several cases of air embolism have been reported when using QUIXIL / EVICEL spray devices with 

pressure regulator due to unproprer use of spray devices, not in accordance with the manufacturer’s recommendations. 

Omrix has reported abour two life-threatening cases of air embolism, one of them resulting in death of a 22-year-old 

patient. 


Type of text : Letter, Red Hand Letter 



Germany - BfArM Statement on Clinical Safety: Nitrofurantoin for the Prophylaxis 

of Recidiving Urinary Tract Infections ( Last Line Indication ) - New Assessment 

of the Benefit-Risk Profile - Jun-2010 

This statement deals with the clinical safety of nitrofurantoin for the prophylaxis of recidiving urinary tract infections. It 

results from the re-assessment of the benefit-risk profile of nitrofurantoin initiated by the BfArM and the Commission of 

Medicinal Products for Pediatric Use ("KAJK") in 2009 following ADR reports and publication of suspicious cases of pulmonary 

fibrosis and liver damage caused by nitrofurantoin. For more information related to this topic, please refer to "BfArM Letter: 

Protection from Drug Risks – Hearing, Stage II - Nitrofurantoin-Containing Medicinal Products - 21-Sep-2010" (114159) and 

"BfArM Statement on Genetic Toxicology: Nitrofurantoin for the Prophylaxis of Recidiving Urinary Tract Infections ("Last Line 

Indication") - New Assessment of the Benefit-Risk Profile" (114143). 

Document date : Jun-2010 




Germany - BfArM Statement on Genetic Toxicology: Nitrofurantoin for the 

Prophylaxis of Recidiving Urinary Tract Infections ( Last Line Indication ) - New 

Assessment of the Benefit-Risk Profile - Jun-2010 

This statement deals with the genetic toxicology (genotoxicity, carcinogenicity and mutagenicity) of nitrofurantoin for the 

prophylaxis of recidiving urinary tract infection. It also provides information on the genotoxicity of other therapeutic 

alternative options: trimethoprim, fluoroquinolone and cephalosporine. This statement results from the re-assessment of the 

benefit-risk profile of nitrofurantoin initiated by the BfArM and the Commission of Medicinal Products for Pediatric Use 

("KAJK") in 2009 following ADR reports and publication of suspicious cases of pulmonary fibrosis and liver damage caused 

by nitrofurantoin. For more information related to this topic, please refer to "BfArM Letter: Protection from Drug Risks – 

Hearing, Stage II - Nitrofurantoin-Containing Medicinal Products - 21-Sep-2010" (114159) and "BfArM Statement on Clinical 

Safety: Nitrofurantoin for the Prophylaxis of Recidiving Urinary Tract Infections ("Last Line Indication") - New Assessment of 

the Benefit-Risk Profile - Jun-2010" (114144). 

Document date : Jun-2010 




Germany - Dear Doctor Letter: On the Potential Risk of Occurrence of Squamous

Epithelial Carcinoma Associated With the Long Term Use of VFEND 

(Voriconazole) – Sep-2010 

Product Name: VFEND INN: voriconazole Marketing Authorization Holder: Pfizer Pharma GmbH In agreement with the 

European Medicines Agency (EMA) and the BfArM, Pfizer Pharma GmbH wishes to inform Healthcare Professionals on the 

potential risk of occurrence of squamous epithelial carcinoma associated with the long term use of VFEND (voriconazole). A 

small number of cases of squamous cell carcinoma of the skin have been identified in patients exposed to long-term 

treatment with VFEND. These patients had developed phototoxicity reactions and additional risk factors, including 

immunosuppression. The role of voriconazole in the development of squamous cell carcinoma remains unknown. Patients 

taking VFEND are recommended to avoid sun exposure during treatment, to wear protective clothing and apply sunscreen. 

VFEND treatment duration should be as short as possible, taking into consideration the patient's mycologic and clinical 

response. 





Germany - Dear Doctor Letter: RELISTOR (methylnaltrexone bromide) – 06-Sep- 

2010 

Product Name: RELISTOR INN: methylnaltrexone bromide Pharmaceutical form: solution for injection Route of 

administration: subcutaneous use Used for treatment: of opioid-induced constipation in advanced illness patients who are 

receiving palliative care when response to usual laxative therapy has not been sufficient. MA holder: Pfizer Pharma GmbH, 

on behalf of Wyeth Europa Ltd. Following post-marketing reports of gastro-intestinal perforations in patients who had 

received a subcutaneous injection of RELISTOR (methylnaltrexone bromide), Pfizer Pharma GmbH, on behalf of Wyeth 

Europa Ltd., recommends Healthcare Professionals: - to use RELISTOR with caution in patients with known or suspected 

lesions of the gastro-intestinal tract. - to advise them to promptly notify their physician if they develop severe, persistent, 

and/or worsening abdominal symptoms. Sections 4.4 “Special Warnings and Precautions for Use” and 4.8 “Adverse Drug 

Reactions” (post-marketing experience) of the product information (SmPC) were updated accordingly. The revised SmPC in 

German language is attached to this Dear Doctor Letter. 





Germany - Federal Ministry of Health: User Guide - Registration for Electronic 

Variation Submission -Version 2.0, Status: 07-Sep-2010 

This user guide deals with recommendations, technical information and detailed procedure for Marketing Authorization 

Holders who wish to submit national or European variations electronically, using the portal PharmNet.Bund. 





Germany - FAQs: On Electronic Variation Notifications - Version 2.0 of 16-Aug- 

2010 

This questions and answers documents deals with the electronic notification of variations using the PharmNet.Bund portal. It 

provides technical, practical and legal information related to this topic. 





Germany - Off-Label Use Expert Group Report of 03-Sep-2010: On the Use of 

Intravenous Immunoglobulin G (IVIG) in the Treatment of Myasthenia Gravis 

This Final Report, dealing with the off label use of of intravenous immunoglobulin G (IVIG) in the treatment of myasthenia 

gravis, has been forwarded to the Federal Committee of Doctors and Health Insurers. The Expert Group concluded that the 

off-label use of intravenous immunoglobulin G (IVIG) is justified in the treatment of myasthenia crisis / acute exacerbation 

of myasthenia gravis when basic treatment has failed. 




Language : German

Germany - Off-Label Use Expert Group Report of 03-Sep-2010: On the Use of 

Verapamil in the Treatment of Cluster Headache 

This Final Report, dealing with the use of verapamil in the treatment of cluster headache, has been forwarded to the Federal 

Committee of Doctors and Health Insurers. The Expert Group concluded that the off-label use of verapamil for oral use is 

justified in the treatment of cluster headache. The adequate dose is between 240 mg and 720 mg per day with minimum 

two intakes. The Expert Group recommends to re-assess the off-label use of verapamil in the treatment of cluster headache 

in four years. 





Greece 

Greece - Circular of EOF 66500/30-09-2010: Circular on Medical Events, 30-Sep- 

2010 

This Circular has been issued by EOF in the context of the changing legislation in the area of medical events to assure the 

proper role of EOF as regards the ethical rules, the financial burden, and the scientific nature of such events. In its 

introductory section, this Circular determines the definitions of a) conferences of scientific content, b) events of medical 

education, and c) events of medical education for pharmaceutical or other type of products, as well as of promotion 

expenses. In particular, this Circular handles specific aspects of events of category (a) above, regarding the evaluation of 

related demands by EOF, the mode and timing for submitting such demands and documentation to EOF, their funding by 

EOF and their sponsoring. For such events, this Circular is valid from 01-Oct-2010 whereas EOF Circular 6434/28-01-2010 

(106158) is no longer valid. However, type (a) event applications submitted to EOF prior to that date will be evaluated 

according to EOF Circular 6434/28-01-2010 (106158), and the submission deadline for new applications is the 31-Oct-2010. 

As regards events of type (b) or (c) above, EOF circular 6434/28-01-2010 (106158) remains valid. 


Type of text : Circular, EOF Circular 


Language : Greek 

Hong Kong 

Hong Kong - Drug News: Issue No. 10, Aug-2010 

This document presents a monthly digest of local and overseas drug safety news and information. July 2010 issue contains 

safety information on: - Ongoing safety review of the angiotensin receptor blockers and cancer by the US FDA - European 

Medicines Agency(EMA) updated on ongoing benefit-risk review of rosiglitazone (Avandia, Avandamet and Avaglim) - 

Positive benefit-risk balance of topical formulations of ketoprofen, a medicine for pain relief and Rotarix, a rotavirus vaccine 

was confirmed by EMA - China SFDA issued the report on risk of 1) rhabdomyolysis associated with the use of lamivudine 

and 2) telbivudine and severe skin reactions associated with the use of isotretinoin, a medicine for acne treatment - 

European Medicines Agency concluded review of modified-release oral opioids of the WHO level III scale for the 

management of pain - Eosinophilic pneumonia associated with the use of Cubicin (daptomycin) reported by the US FDA - 

Association of Relistor (methylnaltrexone bromide) subcutaneous injection with gastrointestinal (GI) perforation reported by 

Health Canada - Aseptic meningitis risk with use of seizure drug Lamictal issued by the US FDA 


Type of text : Newsletter 



Ireland 

Ireland - IMB: Adverse Reaction Reporting to the IMB for 2009, 06-Oct-2010 

This document provides the number of suspected adverse reactions received by IMB in 2009 sorted by source. It also 

summarizes why the IMB encourages adverse reaction reporting and how it manages the submission and the evaluation of 

these reports. 





Italy 

Italy - AIFA Communication of 02-Oct-2010: Prohibition of Sale Some Medicinal 

Products for Human Use

This Communication provides the list of medicinal products which are prohibited from sale. 


Type of text : AIFA Communication, Communication 


Language : Italian 

Italy - AIFA Communication of 05-Oct-2010: Integration in the List of Off-Patent 

Medicinal Products 

This Communication announces the list of medicinal products that the AIFA has declared to be no more covered by patents 

in Italy. 


Type of text : AIFA Communication, Communication 



Italy - Dear Doctor Letter: Important Information on REPLAGAL (agalsidase 

alfa), 04-Oct-2010 

The AIFA in agreement with Shire, wishes to inform health professionals about the extended and severe shortage of 

Fabrazyme, which has conducted to an unprecedented demand of REPLAGAL (agalsidase alfa). Shire is committed to make 

available uninterrupted available and long run REPLAGAL to all patients. It also explains that the company is providing 

Replagal to 80% of Fabry patients in Europe and needs to limit the number of patients treated with this product. 


Type of text : Dear Doctor Letter, Letter 



Italy - Dear Doctor Letter: Important Safety Information on Marketing 

Authorisation Suspension for rosiglitazone-containing Medicinal Products 

(AVANDIA, AVANDAMET, AVAGLIM), 29-Sep-2010 

The European Medicines Agency (EMA) has completed the review of the benefit/risk balance of rosiglitazone-containing 

medicinal products (AVANDIA, AVANDAMET and AVAGLIM) due to cardiovascular risk. The CHMP concluded that the benefits 

of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation in the 

European Union. These products will cease to be available in Europe within the next few months. 


Type of text : Dear Doctor Letter, Letter 



Japan 

Japan - PFSB/ELD Notification No. 0917/1: ICH Guideline Topic Q4B Annex 8 

Step 4: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 

ICH Regions on Microbiological of Non-Sterile Products: Sterility Test General 

Chapter, 17-Sep-2010 (English/Japanese version) 

This ICH Guideline Topic Q4B Annex 8 Step 4: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH 

Regions on Microbiological of Non-Sterile Products: Sterility Test General Chapter has been presented and adopted in Japan. 

The ICH Steering Committee recommends that the official pharmacopoeial texts, European Pharmacopoeia. 2.6.1. Sterility, 

Japanese Pharmacopoeia 4.06 Sterility Test, and United States Pharmacopoeia Sterility Tests, can be used as 

interchangeable in the ICH regions. 

Comment: The English version of the attachment is available as in issued by the ICH committee. ICH Guideline Topic Q4B 

Annex 8 Step 4: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological of 

Non-Sterile Products: Sterility Test General Chapter, 11-Jun-2009 (92899) 


Type of text : Guideline, Notification, PFSB/ICH Guideline 



Japan - PFSB/ELD Notification No. 0917/2: ICH Guideline Topic Q4B: Evaluation 

and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on 

Microbiological Examination of Non-Sterile Products, 17-Sep-2010

(English/Japanese version) 

This document presents the Annexes of ICH Guideline Topic Q4B: Evaluation and Recommendation of Pharmacopoeial Texts 

for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products. This document contains; Annex 4A Step 

4 Microbial Enumerations Test General Chapter, Annex 4B Step 4: Test for Specified Micro-Organisms General Chapter 

Annex 4C Step 4: Acceptance Criteria for Pharmaceutical Preparations and Substances for pharmaceutical Use General 

Chapter The ICH Steering Committee recommends that the official pharmacopoeial texts, European Pharmacopoeia. 2.6.1. 

Sterility, Japanese Pharmacopoeia 4.06 Sterility Test, and United States Pharmacopoeia Sterility Tests, can be used 

as interchangeable in the ICH regions. 

Comment: The English version of the attachment is available as in issued by the ICH committee; ICH Guideline Topic Q4B 

Annex 4A Step 4: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological 

Examination of Non-Sterile Products: Microbial Enumerations Test General Chapter, 12-Nov-2008 (87647) ICH Guideline 

Topic Q4B Annex 4B Step 4: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on 

Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms General Chapter, 12-Nov-2008 

(87651) ICH Guideline Topic Q4B Annex 4C Step 4: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 

ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations 

and Substances for pharmaceutical Use General Chapter, 12-Nov-2008 (87658) 





Japan - PFSB/ELD Notification No. 0917/3: ICH Guideline Topic Q4B Annex 5 

Step 4: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the 

ICH Regions on Disintegration Test General Chapter, 17-Sep-2010 

(English/Japanese version) 

This ICH Guideline Topic Q4B Annex 8 Step 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH 

Regions on Disintegration Test General Chapter has been presented and adopted in Japan. The ICH Steering Committee 

recommends that the official pharmacopoeial texts, European Pharmacopoeia. 2.6.1. Sterility, Japanese Pharmacopoeia 

4.06 Sterility Test, and United States Pharmacopoeia Sterility Tests, can be used as interchangeable in the ICH 

regions. However, testing conditions for specific dosage forms are outside the scope of the harmonization. 

Comment: The English version of the attachement is available as in issued by the ICH committee. ICH Guideline Topic Q4B 

Annex 5 Step 4: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test 

General Chapter, 10-Jun-2009 (92894) 





New Zealand 

New Zealand - Fees payable under the Medicines Act 1981, 01-Oct-2010 

This document provides a summary of fees and charges for: - New Medicine Application (NMA), - New Medicine Application 

(Abbreviated Evaluation Process), - New Related Product Application (NRPA), - New Medicine Application (Provisional 

Consent), - Changed Medicine Notifications (CMN), - Change Related Product Notification (CRPN), - Clinical Trial Application, 

- Licences and Other. 





Portugal 

Portugal - INFARMED Pharmacovigilance Bulletin Volume 14 - No. 3, 3rd Quarter 

2010 - (Portuguese and English Versions) 

This Bulletin published by the Infarmed deals with pharmacovigilance issues during the 3rd Quarter 2010. 


Type of text : Bulletin, Pharmacovigilance Bulletin 



Portugal - INFARMED Information Circular 156/CD (24-Sep-2010) Corr.: MA 

Suspension and Immediate Recall of OCTAGAM 5% and 10% (Normal Human

Immunoglobulin), Solution for Intravenous Use 

Safety Information. The Infarmed wishes to inform on the EMA's decision to suspend the Marketing Authorisation of 

OCTAGAM 5% and 10% (Human Immunoglobulin), solution for intravenous use and to recall immediately all batches 

available in the European market. Thus, the Infarmed announces that all batches of OCTAGAM 5% and 10% will be recalled 

from the Portuguese market. The reason of this EMA's recommendation is due to an increase in thromboembolic events. 

Health professionals should switch to other alternative treatment. A list of other medicinal products with normal human 

immunoglobulin as active ingredient is available in this document. 


Type of text : Circular, Information Circular 



Saudi Arabia 

Saudi Arabia - Guidelines for Drug Master File, Version 1.1, 01-Sep-2010 

This guidance document applies to all Drug Master File (DMF) owners and their authorized agent, holders of pharmaceutical 

or biological drugs and veterinary drug applications using a DMF to support their application and SFDA staff involved in the 

DMF processing and assessing. It is intended to provide assistance and information required by SFDA for filing a DMF. This 

document provides definitions of terms related to DMFs, details the administrative procedures and requirements and provide 

information on the content of the several categories (Type I, II and III). This final version updates the product evaluation 

and standards setting Department. The guidance document is in line with the ICH guidelines. 

Comment: This document replaces the draft Guidelines for Drug Master File, Aug-2009 (102318). 





South Africa 

South Africa - Form: Application For The donation of Medicine to South Africa, 

Version 2, Sep-2010 

This ready-to-use form is intended to applicant who whishes to donate medecines. The application should be completed by 

applicant and returned to the MCC. All medicine donations should be based on the health needs and disease pattern of 

South Africa. This application has been updated to include new contact details and reference to MRF1/ZA-CTD dossier. The 

guideline on Medicine Donations is also available (114129). 





South Africa - Guideline: Medicine Donations to South Africa, Version 2, Sep- 

2010 

According to this guideline, all medicine donations should be based on the health needs and disease pattern of South Africa. 

Medicines should not be sent without prior consent by the recipient. The purpose of this guideline is to improve the quality 

of medicine donations and provides requirements on the quality assurance, shelf life and the presentation of packaging and 

labelling. It is intended to serve as a base for national guideline, to be reviewed, adapted and implemented by the 

government and organizations dealing with drug donations. No donated medicines may be used unless the MCC has 

specifically authorized its use. Application for the donation of medicine must be made to the Registrar of Medicines, by 

suppling the following information: name, expiry date, batch number, package, site of manufacture, package insert, 

quantity, intended for and local recipient. This document has been update to include new contact details and reference to 

South Africa CTD. An application for the donation of medicine is available (114157). 

Comment: This docuument replaces the Guideline: Medicine Donations to South Africa, Version 2, May-2003 (41313). 





South Africa - Guideline: Post-Registration Amendments, Version 4.2, Sep-2010 

This guideline has been prepared as a tool to address all matters concerning amendments to facilities (including change in 

the Holder of a Certificate of Registration (HCR)) and pharmaceutical and analytical aspects of the medicine. Are concerned 

by this amendment: - holder of the certificate of registration (HCR) to registered medicines; - Applicant of old medicines; - 

proposed holder of the registration certificate (PHCR) / Applicant in response to committee recommendations. The guideline 

provides the format required for the submission of pre- and post-registration amendment and also provides the differents 

types of amendments identified as follow: - Type A (amendments that may be implemented without intervention of or prior

notification to Council - Type B (amendments that require prior notification) - Type C (amendments that require prior 

approval) - Type D (amendments that should be considered new applications). This guideline outlines also the process to be 

followed when submitting an annual viral strain change for influenza vaccines and provides requirements on legend for 

stability data. The Version 4.2 of the post-registration amendments Guideline bring correction to section 7.3 Categories 8a 

and 8b. Case A and Case B dissolution were the wrong way round in the previous version. 

Comment: This document replaces the post-registration amendments Guideline version 4.1 (109814) 





Sweden 

Sweden - Information Note: DCP with Sweden as RMS, 15-Sep-2010 (Swedish 

and English Versions) 

This information note gives all the details including slot times for Sweden acting as RMS in the DCP. Due to limited 

resources, the Agency specifies the prioritisation criteria which will be applied for the submitted requests. 

Comment: This document replaces "Information Note: DCP with Sweden as RMS, 27-Jan-2009 (Swedish and English 

Versions)" (88593). 





Switzerland 

Switzerland - Clinical Research: General Principles 

This document provides information on the general principles in clinical research in Switzerland. 




Switzerland - Swissmedic Communication: Increase Risks of Febrile Reactions in 

Children in Australia Following Vaccination Against Seasonal Flu, 04-Oct-2010 

(German and French Versions) 

This document is a communication of Swissmedic and BAG. It deals with an increase of convulsions reported in Australia in 

children aged under five after the administration of Fluvax, the trivalent vaccine against seasonal flu. This increase of risks 

was reported only in Australia and only with the preparation from the Australian manufacturer CSL Ltd. No flu vaccine from 

CSL Ltd Australia is sold on the Swiss market and no convulsions in children have been reported in Switzerland. Therefore, 

risk of increase incidence of febrile reactions after administration of vaccine against seasonal flu is low in Switzerland. 

However, during the vaccination campaign against the seasonal flu for 2010/2011, the healthcare professionals and patients 

are asked to be vigilant to febrile reactions with children. 





Switzerland - Dear Doctor Letter: Suspension of AVANDIA and AVANDAMET 

(Rosiglitazone), 04-Oct-2010 (German and French Versions) 

Swissmedic decided to suspend the marketing authorization of GlaxoSmithKline SA for medicinal products containing 

rosiglitazone because of cardiovascular risks. In Switzerland, the medicinal products concerned are the treatments for 

diabetes Avandia and Avandamet (rosiglitazone). These medicinal products will no longer be for sale from 01-Dec-2010. See 

also "Swissmedic Communication: Cardiovascular Risk Associated with AVANDIA and AVANDAMET tablets preparations 

(rosiglitazone / metformin) in the Treatment of Diabetes, 03-Aug-2010" (111493). 


Type of text : Dear doctor letter 



Switzerland - Ordinance of 08-Sep-2010: Modification of Ordinance of 17-Oct- 

2001 on Pharmacopoeia (OPha) (German, French and Italian Versions) 

This modification of "Ordinance of 17-Oct-2001 on Pharmacopoeia (OPha)" (114014) amends: - Art. 2a -Art. 4, al. 1.

Comment: This text amends "Ordinance of 17-Oct-2001: Ordinance on Pharmacopoeia (OPha)"(114014). 


Type of text : Ordinance 

Regulatory version : Amendment 


Switzerland - Ordinance of 10-Sep-2010: Amendment to Ordinance of 09-Nov- 

2001 Regarding Pharmacopoeia and the Recognition of Other Pharmacopoeia 

(German, French and Italian Versions) 

This modification of "Ordinance of 09-Nov-2001: Swiss Institute of Therapeutic Products Ordinance Regarding 

Pharmacopoeia and the Recognition of Other Pharmacopoeia" (94067) concerns the Art. 1. 

Comment: This document amends "Ordinance of 09-Nov-2001: Swiss Institute of Therapeutic Products Ordinance 

Regarding Pharmacopoeia and the Recognition of Other Pharmacopoeia" (94067). 



Regulatory version : Amendment 


Switzerland - Ordinance of 17-Oct-2001: Clinical Trials of Therapeutic Products 

(VKlin/OClin), Status 01-Oct-2010 (German, French and Italian Versions) 

The aim of this Ordinance is to guarantee the protection of persons undergoing clinical trials of therapeutic products and to 

ensure the quality of the clinical trials. This Ordinance applies to clinical trials of therapeutic products and to clinical trials of 

somatic gene therapy. It doesn't apply to clinical trials with/using live organs, tissues or cells of human or animal origin nor 

to ex vivo gene therapy. Clinical trials of medicinal products must conform to the ICH directives on Good Clinical Practice of 

May 1st, 1996 (16937). Clinical trials of medical devices must conform to the annexes VIII and X of Directive 93/42/EEC 

(30528) and to annexes VI and VII of Directive 90/385/EEC. This consolidated version takes into consideration the 

modifications brought by the last amendment of 08-Sep-2010 (113494). 

Comment: This consolidated version replaces the last amended version, status 01-Apr-2010 (113324). This is the last 

consolidated version of the ordinance of 17-Oct-2001 (31891). 



Regulatory version : Amended 


Switzerland - Ordinance of 17-Oct-2001: Ordinance on Pharmacopoeia (OPha) 

(Status 01-Oct-2010) (German, French and Italian Versions) 

This document provides the Ordinance on Pharmacopoeia in Switzerland, in accordance with the "Federal Law on 

Therapeutic Products and Medical Devices" (28388). This consolidated version takes into consideration the modifications 

brought by the last modification of 08-Sep-2010 (114019). 

Comment: This consolidated version replaces the last amended version, Status 11-Dec-2001 (81722). This is the last 

consolidated version of the ordinance of 17-Oct-2001 (114014). 



Regulatory version : Amended 


Taiwan 

Taiwan - Announcement: All Related Medical Institutions Should Do to Comply 

with Article 15 of the Regulations of Clinical Trial Management, 23-Sep-2010 

(Taiwanese version) 

In order to respect the right of the patients and maintain the medical order, during the clinical trial, all related medical 

institutions should do to comply with Article 15 of the Regulations of clinical trial management (DOH No. 0980263557, 14- 

Dec-2009(100707)), which is "during the clinical trial, the medical institutions should not publish or publicize results". 


Type of text : Announcement 


Language : Taiwanese 

Taiwan - Announcement: PIC/S GMP Assessment Letter of the Compliance 

Documents, 24-Sep-2010 (Taiwanese version) 

When the sponsor applies for Marketing Approval, DOH would accept the PIC/S GMP assessment letter of compliance

documents for the information of the same dosage form which replace the individual assessment letter including; the 

preparation letter of F No. manufacture GMP, the data of the foreign pharmaceutical factory (PMF) the overseas factory 

inspection and the related assessment letter, item B of phase 1,2,3. 




Language : Taiwanese 

Turkey 

Turkey - IEGM Announcement of 27-Sep-2010: to the Attention of Companies 

Submitting GMP Certificate Applications 

This Announcement has been published in order to provide the names of the signatory Heads of Department to be added at 

the end of certificates and clarify that in the CPP, in part 3.1, periodicity should be "once every 3 years". 




Language : Turkish 

Turkey - By-Law: Traditional Herbal Medicinal Products, 06-Oct-2010 

The aim of this By-Law is to lay down the procedures and principles for the marketing authorisation and quality, safety and 

efficacy compliance of traditional herbal medicinal products and herbal preparations, prepared from medicinal plants having 

proven their preventive and curative effects on human health as well as their traditional use. This By-Law has been written 

in accordance with the Law No. 1262 on Pharmaceutical and Medical Preparations (60243), Law No. 3359 on Fundamental 

Healthcare (61290), Article 3, paragraph 1, f), and Decree-Law No. 181 on Organisation and Tasks of the Ministry of Health 

(60352), Article 43. This By-Law implements the EU Directive 2001/83/EC (37421) and 2004/24/EC (44200). 


Type of text : By-Law, Law 

Regulatory version : Implementation 

Language : Turkish 

United Kingdom 

United Kingdom - Prescription and Supply Requirements 

This document provides information on the prescription and supply requirements (classification for the supply of medicinal 

products) (implementation of Directive 92/26/EEC). 




United Kingdom - MHRA: Review of Medicines Legislation: Informal Consultation 

on the Medicines Act 1968 Exemptions for Sale, Supply and Administration of 

Medicines, 04-Oct-2010 

This draft document aims to undertake a review of the legal provisions which allow health professionals and others to sell, 

supply and/or administer medicines by way of exemptions from the usual Medecines Act restrictions. The document sets out 

the current legal provisions for exemptions together with initial proposals for retension, removal or amendment. The 

Medicines Act exemptions are set out in the Prescription Only Medicines (Human Use) Order 1997 (14457) and the 

Medicines (Pharmacy and General Sale - Exemption Order) 1980 (4352). Further provisions relating to persons who may 

receive wholesale supplies of medicines are contained in the Medicines (Sale or Supply) (Miscellaneous Provisions) 

Regulations 1980 (4350). In addition a proposal is being considered to replace the present system for legally specifying list 

of medicines and any conditions attached to the exemptions; instead the choice of medicines available to health 

professionals would be determined by the relevant statutory body as appropriate to professional practice. The consultation 

document contains the following Annexes: Annex A: Exemption for parenteral administration in an emergency to human 

beings of certain prescription only medicines (extract from to POM Order 1997 as amended; Aticle 7 from 30-Jun) Annex B: 

List of persons who can receive medicines by way of wholesale dealing. 

Comment: Deadline for comments: 01-Nov-2010 


Type of text : Consultation 



United Kingdom - Dear Doctor Letter: Change to the Formulation of EVOTROX,

ALMUS LEVOTHYROXINE (levothyroxine sodium), 14-Sep-2010 

Kappin Ldt has made a change to the formulation of strengths of EVOTROX, ALMUS LEVOTHYROXINE containing active 

ingredient levothyroxine sodium. As a result of this, there will be an increase of approximately 10% in potency of this 

product. This change is effective immediately and will affect all batches manufactured on or after Aug-2010. These packs 

will be marked with 'New Formulation' on the packaging. The recommended dose has not changed. 


Type of text : Dear Doctor Letter 



United Kingdom - Dear Doctor Letter: Important Information on CEREZYME 

(imiglucerase) - Update on the Supply and Recommendations on Treatment for 

Patients, 23-Sep-2010 

Genzyme would like to inform that the supply of CEREZYME (imiglucerase) from October 1st 2010 onwards will be improved 

to approximately 85% of global demand. It is foreseen that this supply status will remain in place until at least June 2011. 

As inventories remain tight, Cerezyme supply remains vulnerable to disruption due to delays or unexpected manufacturing 

events. Genzyme expect to be able to supply enough Cerezyme to allow patients currently treated with Cerezyme at a 

reduced dose or at a reduced infusion frequency to be dosed per the approved SmPC, under the supervision of their treating 

physician. 





United Kingdom - Dear Doctor Letter: Important Information on the Change 

From IMPLANON to NEXPLANON, 03-Sep-2010 

MSD would like to inform about the replacement of IMPLANON in mid October 2010 by NEXPLANON a radio-opaque with a 

new insertion mechanism designed to reduce the risk of insertion difficulties. The active hormone contained in NEXPLANON 

is etonogestrel 68 mg. It is a subdermal contraceptive implant and bioequivalent to IMPLANON. The questions and answers 

provide information about: - what is changing or staying the same; - user of Implanon; - what to do if you do not currently 

fit Implanon, but wish to start using Nexplanon; - how will the change-over be managed; - the remaining stock of 

Implanon; - the reporting of adverse reaction. 





United Kingdom - Dear Doctor Letter: Recall of AVANDIA and AVANDAMET 

(rosiglitazone), 01-Oct-2010 

Following the recommendation by the EMA on 23-Sep-2010 (113653) to suspend the marketing authorisation across Europe 

of rosiglitazone containing medicines AVANDIA and AVANDAMET, GlasoSmithKline Ltd would like to inform that AVANDIA 

and AVANDAMET will not be available in the UK after 21st October 2010. From this date GSK will recall stocks of 

Avandia/Avandamet; undispensed UK packs purchased from GSK through approved suppliers, Alliance Healthcare and AAH 

Pharmaceuticals, may be returned for credit. It has therefore provided recommendations to ensure a smooth transition for 

patients. 





USA 

USA - FDA Inspectors Table (last updated 08-Oct-2010) 

The FDA Inspectors Table is a listing of all Establishment Inspection Reports (EIRs), FDA 483s, and Warning Letters 

available in IDRAC, categorized alphabetically by FDA inspector name. The list includes names of firms or individuals 

(clinical investigators) inspected, the type of establishment inspected, and links to related EIRs and Warning Letters. 

Contact details for FDA District Offices are also included in this document. 

Comment: Latest updates: - (114026) John A. Ward, MD - Investigator Patricia S. Smith. - (113524) CFH Laboratories, LP 

- Investigators Kelli F. Regenye and Frank Marciniak. - (114169) Burzynski Research Institute IRB - Investigator: Patrick D. 

Stone. 



Language : English

USA - Guidance Bulletins: Table of Contents 

This document which initially contained the table of contents of Guidance Bulletins has been replaced to now include a more 

comprehensive table listing all guidance bulletins in IDRAC with their date of inclusion/revision and their status 

(simple/comparison) classified thematically in alphabetical order and providing additional details as regards the status of 

relevant FDA guidances (draft/final), docket numbers of public comments, with links to the guidance bulletins and docket 

numbers. 

Comment: New: - Suicidality: Prospectve Assessment of Occurence in Clinical Trials (114168) 




USA - List of New Molecular Entities (NMEs), 2010 

This document contains the list of NMEs approved in calendar year 2010 with all relevant details - NDA Number, Approval 

Date, Generic and Trade Names, Dosage form, Applicant's Name, Classification, and Indications for which they have been 

approved. 

Comment: This document has been revised to include the Reviews for ELLA. 




USA - FDA Workshop Bulletin: Advancing Development of Medical Products Used 

in the Prevention, Diagnosis, & Treatment of Neglected Tropical Disease, 23-Sep- 

2010 

This FDA public workshop was held to solicit comments and input from interested parties and stakeholders on issues 

regarding the advancement of drugs, biological products, and medical devices used in the prevention, diagnosis and 

treatment of rare and neglected tropical diseases (NTD). 


Type of text : FDA Workshop Bulletin 


USA - Regulatory Timetable for the Federal Register 2010 (Last Updated 08-Oct- 

2010) 

Regulatory Timetable for the Federal Register 2010. 


Type of text : Federal Register Regulatory Timetable 


USA - Guidance Bulletin: Suicidality - Prospective Assessment of Occurrence in 

Clinical Trials, 07-Oct-2010 

This guidance bulletin summarizes the content and regulatory history of the FDA Guidance for Industry: "Suicidality - 

Prospective Assessment of Occurence in Clinical Trials" and provides links to public dockets/comments and IDRAC search 

information related to the topic of the guidance. 


Type of text : Guidance Bulletin 


USA - Corporate Integrity Agreement between the Office of Inspector General of 

the Department of Health & Human Services and Synthes, Inc., 01-Oct-2010 

Synthes, Inc. entered into this Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United 

States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, and written 

directives of Medicare, Medicaid, and all other Federal health care programs. Contemporaneously with this CIA, Synthes, 

Inc. is entering into a Settlement Agreement with OIG. 


Type of text : Agreement 



USA - Biologics License Application (BLA): KRYSTEXXA (pegloticase) - Approval

Letter, Labeling and REMS, 14-Sep-2010 

This biologics license application, BLA 125293/0, provides for the use of KRYSTEXXA (pegloticase) for the treatment of 

chronic gout in adult patients refractory to conventional therapy. This document contains the approval letter,labeling and 

REMS. - Drug Name: KRYSTEXXA - Active ingredient: pegloticase - Applicant: Savient Pharmaceuticals, Inc. - Indications: it 

is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. - Pharmacotherapeutic 

class (ATC Code): other antigout preparations - M04AX02 - Pharmaceutical form: injection - Packaging: vial - Route of 

administration: intravenous use - Review classification: O (Orphan Review Drug) - Boxed warning: Yes - Medication Guide: 

Yes - REMS: Yes - Pediatric Indication: No N.B.: This exclusive document has been prepared by IDRAC by integrating the 

files released by the FDA into one comprehensive document. It is also enriched with Cover Pages and a detailed Table of 

Contents provided in the left frame. 

Comment: This document has been revised to include the REMS document for KRYSTEXXA. 


Type of text : Approval Package 



USA - Drug Approval Package: GILENYA (fingolimod) - Approval Letter, Labeling 

and REMS, 21-Sep-2010 

This new drug application, NDA 22-527, provides for the use of GILENYA (fingolimod) 0.5 mg capsules for the treatment of 

patients with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the accumulation of 

physical disability. This document contains the approval letter,labeling and REMS. - Drug Name: GILENYA - Active 

Ingredient: fingolimod - Applicant: Novartis Pharmaceutical Corporation - Indications: it is indicated for the treatment of 

patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the 

accumulation of physical disability. - Pharmaceutical form: capsule - Packaging: blister - Route of administration: oral use - 

Boxed warning: No - Medication Guide: Yes - REMS: Yes - Pediatric Indication: No N.B.: This exclusive document has been 

prepared by IDRAC by integrating the files released by the FDA into one comprehensive document. It is also enriched with 

cover pages and a detailed Table of Contents provided in the left frame. 

Comment: This document has been revised to include the REMS document for GILENYA. 





USA - Drug Approval Package: ella (ulipristal acetate) - Approval Letter, 

Labeling, Summary Review, Officer/Employee List, Office Director Memo, Cross 

Discipline Team Leader Review, Reviews (Medical, Chemistry, Pharmacology, 

Statistical, Clinical Pharmacology and Biopharmaceutics, Proprietary Name and 

Other) and Administrative and Correspondence Documents 13-Aug-2010 

This new drug application, NDA 22-474, provides for the use of ella (ulipristal acetate) 30 mg tablet for the prevention of 

pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine 

use as a contraceptive. This document contains the Approval Letter, Labeling, Summary Review, Officer/Employee List, 

Office Director Memo, Cross Discipline Team Leader Review, Reviews (Medical, Chemistry, Pharmacology, Statistical, Clinical 

Pharmacology and Biopharmaceutics, Proprietary Name and Other) and Administrative and Correspondence Documents. - 

Drug Name: ella - Active Ingredient: ulipristal acetate - Applicant: Laboratoire HRA Pharma - Indications: indicated for 

prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. - 

Pharmacotherapeutic class (ATC Code): Progestogens (ATC G03AC) - Pharmaceutical form: tablet - Packaging: blister - 

Route of administration: oral use - Boxed warning: No - Medication Guide: No - REMS: No - Pediatric Indication: Yes N.B.: 

This exclusive document has been prepared by IDRAC by integrating the files released by the FDA into one comprehensive 

document. It is also enriched with cover pages and a detailed Table of Contents provided in the left frame. 

Comment: This document has been revised to include the Summary Review, Officer/Employee List, Office Director Memo, 

Cross Discipline Team Leader Review, Reviews (Medical, Chemistry, Pharmacology, Statistical, Clinical Pharmacology and 

Biopharmaceutics, Proprietary Name and Other) and Administrative and Correspondence Documents for ELLA. 





USA - Warning Letter Close-Out Letter: Victus, Inc., 07-Oct-2010 

The Company Victus, Inc. (Miami, Florida) has taken corrective action to address the violations contained in the Warning 

Letter (100443) 

Comment: FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an 

evaluation of corrective actions undertaken by a firm in response to a Warning Letter


Type of text : Close-Out Letter, Letter 



USA - Curriculum Vitae (CV) of Atul Kumar, MD - Member of the Gastrointestinal 

Drugs Advisory Committee for the period 2010-2013 

This document contains the Curriculum Vitae (CV) of Atul Kumar, MD, Member of the Gastrointestinal Drugs Advisory 

Committee for the period 2010-2013 


Type of text : Curriculum Vitae 



USA - Burzynski Research Institute (Institutional Review Board), 03-10-Dec- 

2008: FDA 483 

This inspection of Burzynski Research Institute (IRB - Houston Texas) revealed that the IRB did not adhere to the applicable 

statutory requirements and FDA regulations governing the protection of human subjects. Four deviations are reviewed in 

this document. N.B.: This document has been prepared by IDRAC by integrating FDA documents acquired under the 

Freedom of Information Act, into one comprehensive document. 

Document date : 10-Dec-2008 

Type of text : EIR 



USA - CFH Laboratories, LP, 04-27-Sep-2001: EIR, FDA 483 and Correspondence 

The FDA conducted an inspection of CFH Laboratories, LP’s finished dosage pharmaceutical and Class II non-implantable, 

non-trackable, and non-sterile medical device manufacturer as per NWJ-Do’s 2001 Workplan and FACTS assignment 

#223117, OP ID#657708 in accordance with Compliance Program 7356.002, Drug Process Inspections, and 7382.830, 

Inspection of Medical Device Manufacturers. The previous inspection conducted on 5/11-13, 17/99 was a classified VAI. The 

current Inspection was conducted under the Drug Manufacturing Pilot Program. During the pharmaceutical portion of the 

inspection, the Quality and Production Systems were covered. The current inspection revealed deficiencies in the firm’s 

pharmaceutical and medical device areas of operation. The pharmaceutical observations included are lack of blend 

uniformity testing for 25 mEq Potassium Bicarbonate effervescent tablets for the 2 lots manufactured during the fall 1999 

revalidation study, deficiencies in process validation for Potassium Bicarbonate, USP, and the Aluminum Acetate,USP. In 

addition, an explanation of waste for all 3-validation lots manufactured during the revalidation study, No SOP’s for handling 

Investigations or Production Incident reports regarding batch failures and discrepancies for all products manufactured by 

CFH Laboratories. The medical device deficiencies observed during the inspection, include failure of the firm to document an 

investigation regarding contamination, failure to identify and quarantine tablets and failure to document in the equipment 

cleaning. In addition, deficiencies pertaining to batch records were observed. The Form FDA 483 and Correspondence are 

attached to this document. 15 deviations are reviewed in this document N.B.: This document has been prepared by IDRAC 

by integrating FDA documents acquired under the Freedom of Information Act, into one comprehensive document. 





USA - John A. Ward, M.D. (Capstone Clinical Trials, Inc.), 12-20-May-2009: FDA 

483 

This inspection of Dr John A. Ward, principal investigator for Capstone Clinical Trials, Inc. (Birmingham, Alabama) revealed 

violations of Good Clinical Practice. Four deviations are reviewed in this document. N.B.: This document has been prepared 

by IDRAC by integrating FDA documents acquired under the Freedom of Information Act, into one comprehensive 

document. 

Document date : 20-May-2009 




USA - FDA Enforcement Report, 06-Oct-2010 

List of recalls for the first week of October 2010. 


Type of text : Enforcement, Enforcement Report



USA - Federal Register: Agency Information Collection Activities; Proposed 

Collection; Comment Request; Additional Criteria and Procedures for Classifying 

Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not 

Misbranded (Notice), 08-Oct-2010 

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of 

certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to 

publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public 

comment in response to the notice. This notice solicits comments on the additional criteria and procedures for classifying 

over-the-counter (OTC) drugs as generally recognized as safe and effective and not misbranded. 


Type of text : Federal Register Announcement, Notice 



USA - Federal Register: Agency Information Collection Activities; Proposed 

Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, 

Filing, Format, and Content of Petitions (Notice), 05-Oct-2010 

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of 

certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to 

publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension 

of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice 

solicits comments on FDA’s patent term restoration regulations on due diligence petitions for regulatory review period 

revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and 

Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the 

regulatory review time if FDA marketing approval was not pursued with ‘‘due diligence.’’ 





USA - Federal Register: Agency Information Collection Activities; Submission for 

Office of Management and Budget Review; Comment Request; Export of Food 

and Drug Administration Regulated Products: Export Certificates (Notice), 05- 

Oct-2010 

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the 

Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This 

document concerns Export of Food and Drug Administration Regulated Products: Export Certificates. 





USA - Federal Register: Approval Pathway for Biosimilar and Interchangeable 

Biological Products; Public Hearing; Request for Comments (Notice of public 

hearing; request for comments), 05-Oct-2010 

The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and 

challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). 

The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘‘highly 

similar’’ (biosimilar) to, or ‘‘interchangeable’’ with, an FDA-licensed biological product. The purpose of this public hearing is 

to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute. FDA will 

take the information it obtains from the public hearing into account in its implementation of the BPCI Act. DATES: The public 

hearing will be held November 2 and 3, 2010, from 8:30 a.m. to 4:30 p.m. 




Language : English

USA - Federal Register: Food and Drug Administration Modernization Act of 

1997: Modifications to the List of Recognized Standards, Recognition List 

Number: 025 (Notice), 04-Oct-2010 

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the 

list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, 

entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 025’’ (Recognition List Number: 025), 

will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for 

medical devices. 





USA - Federal Register: Gastrointestinal Drugs Advisory Committee; Notice of 

Meeting (Notice), 05-Oct-2010 

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). 

The meeting will be open to the public. Name of Committee: Gastrointestinal Drugs Advisory Committee. Date and Time: 

The meeting will be held on November 4, 2010, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, 

The Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301–977– 8900. Agenda: On November 

4, 2010, the committee will discuss the adequacy of endoscopically documented gastric ulcers as an outcome measure to 

evaluate drugs intended to prevent gastrointestinal complications of nonsteroidal anti-inflammatory drugs including aspirin. 





USA - Federal Register: Medical Device User Fee and Modernization Act; Notice to 

Public of Web site Location of Fiscal Year 2011 Proposed Guidance Development 

(Notice), 01-Oct-2010 

The Food and Drug Administration (FDA) is announcing the Web site location where it will post a list of guidance documents 

the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a 

docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or 

different guidances. 





USA - Federal Register: Single-Ingredient Oral Colchicine Products; Enforcement 

Action Dates (Notice), 01-Oct-2010 

The Food and Drug Administration (FDA or agency) is announcing its intention to take enforcement action against 

unapproved single-ingredient oral colchicine products and persons (A ‘‘person’’ includes individuals, partnerships, 

corporations, or associations (section 201 (17001) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 

321(e)).) who manufacture or cause the manufacture of such products or their shipment in interstate commerce. 

Unapproved single-ingredient oral colchicine products have been associated with serious adverse events, including fatalities. 

Single-ingredient oral colchicine products are new drugs that require approved applications because they are not generally 

recognized as safe and effective. Currently one firm has obtained approved applications to market single-ingredient oral 

colchicine for the treatment of acute gout flares, prophylaxis of gout flares, and prophylaxis of attacks of Familial 

Mediterranean Fever (FMF). All other manufacturers who wish to market single-ingredient oral colchicine products for these 

or other indications must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application 

(ANDA). 





USA - Draft Guidance on Azathioprine - Tablet, Sep-2010 

This document describes the bioequivalence recommendations for Azathioprine - Tablet. 


Type of text : Guidance for Industry, Guideline 


Language : English

USA - Draft Guidance on Bexarotene - Capsule, Sep-2010 

This document describes the bioequivalence recommendations for Bexarotene - Capsule. 





USA - Draft Guidance on Bosentan - Tablet, Sep-2010 

This document describes the bioequivalence recommendations for Bosentan - Tablet. 





USA - Draft Guidance on Calcipotriene - Ointment, Aug-2010 (Revised Sep-2010) 

This document describes the bioequivalence recommendations for Calcipotriene - Ointment. 

Comment: A previous draft guidance was published in August 2010 (112630). 





USA - Draft Guidance on Calcitriol - Capsules, Jul-2008 (Revised Sep-2010) 

This document describes the bioequivalence recommendations for Calcitriol - Capsules. 





USA - Draft Guidance on Cefadroxil, Cefadroxil Hemihydrate - Capsule, Sep-2010 

This document describes the bioequivalence recommendations for Cefadroxil, Cefadroxil Hemihydrate - Capsule. 





USA - Draft Guidance on Cefdinir - Capsules, Jan-2008 (Revised Sep-2010) 

This document describes the bioequivalence recommendations for Cefdinir - Capsules. 





USA - Draft Guidance on Ciprofloxacin Hydrochloride - Tablet, Sep-2010 

This document describes the bioequivalence recommendations for Ciprofloxacin Hydrochloride - Tablet. 





USA - Draft Guidance on Colchicine - Tablet, Sep-2010 

This document describes the bioequivalence recommendations for Colchicine - Tablet. 





USA - Draft Guidance on Colesevelam Hydrochloride - Tablets, Jul-2008 (Revised 

Dec-2009, Jun-2010, Sep-2010) 

This document describes the bioequivalence recommendations for Colesevelam Hydrochloride - Tablets. 

Comment: A previous draft guidance was published in June 2010 (110434).





USA - Draft Guidance on Doxepin Hydrochloride - Tablet, Sep-2010 

This document describes the bioequivalence recommendations for Doxepin Hydrochloride - Tablet. 





USA - Draft Guidance on Furosemide - Tablet, Sep-2010 

This document describes the bioequivalence recommendations for Furosemide - Tablet. 





USA - Draft Guidance on Metoclopramide Hydrochloride - Orally Disintegrated 

Tablet, Sep-2010 

This document describes the bioequivalence recommendations for Metoclopramide Hydrochloride - Orally Disintegrated 

Tablet. 





USA - Draft Guidance on Metronidazole - Tablets, Sep-2010 

This document describes the bioequivalence recommendations for Metronidazole - Tablets. 





USA - Draft Guidance on Penbutolol Sulfate - Tablet, Sep-2010 

This document describes the bioequivalence recommendations for Penbutolol Sulfate - Tablet. 





USA - Draft Guidance on Tretinoin - Capsule, Sep-2010 

This document describes the bioequivalence recommendations for Tretinoin - Capsule. 





USA - Draft Guidance on Zolpidem - Sublingual Tablets, Sep-2010 

This document describes the bioequivalence recommendations for Zolpidem - Sublingual Tablets. 





USA - Warning Letter: Absolute Packaging, Inc., 09-Sep-2010 

An inspection of Absolute Packaging (Melbourne, Florida) revealed significant violations of Current Good Manufacturing 

Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. Six 

deviations are reviewed in this warning letter. 


Type of text : Letter, Warning Letter



USA - Warning Letter: Actelion Pharmaceuticals, U.S., Inc., 14-Sep-2010 

An inspection of Actelion Pharmaceuticals (South San Francisco, California) revealed that the firm failed to comply with the 

postmarketing reporting requirements under Section 505 of the federal Food, Drug and Cosmetic Act and Regulations Title 

21, (21 C.F.R.) Section 314.80. Two deviations are reviewed in this warning letter. 


Type of text : Letter, Warning Letter 



USA - Warning Letter: BCIW, Inc., 19-Jul-2010 

An inspection of BCIW (Los Angeles, California) revealed deviations from current Good Manufacturing Practice (CGMP) 

Requirements of the Quality System Regulation 21 CFR 803 and 820. Two deviations are reviewed in this warning letter. 

Document date : 19-Jul-2010 




USA - Warning Letter: Capricorn Pharma, Inc., 20-Apr-2010 

An inspection of Capricorn Pharma (Frederick, Maryland) revealed significant violations of Current Good Manufacturing 

Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. Seven 


Document date : 20-Apr-2010 




USA - Warning Letter: Fresenius Medical Care Holdings, Inc., 15-Sep-2010 

An inspection of Fresenius Medical Care Holdings (Waltham, Massachusetts) revealed violations of Current Good 

Manufacturing Practice (CGMP) of Quality System Regulations Title 21, (C.F.R.) Part 820. Five deviations are reviewed in 

this warning letter. 





USA - Warning Letter: Gilead Sciences, Inc., 21-Sep-2010 

An inspection of Gilead Sciences (San Dimas, California) revealed significant violations of Current Good Manufacturing 

Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. Five 






USA - Warning Letter: Joel Picus, M.D. (Washington University of St Louis), 20- 

Sep-2010 

An inspection of Dr. Joel Picus (Washington University of St. Louis), revealed that Dr. Picus did not adhere to the applicable 

statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human 

subjects. Four deviations are reviewed in this warning letter. 





USA - FDA Regulatory Procedures Manual (RPM), March 2010 Edition 

The Regulatory Procedures Manual provides FDA personnel with information on internal procedures to be used in processing 

domestic and import regulatory and enforcement matters. While the RPM is intended mainly to provide guidance to FDA 

inspectors, investigators, and compliance officers, the document is useful to all of FDA. The following chapters are available 

in this document: Ch. 1: REGULATORY ORGANIZATION - An overview of offices involved in compliance related functions 

within FDA. Ch. 2: FDA AUTHORITY - Selected Amendments to the Federal Food, Drug, and Cosmetic Act and other laws of

interest. Ch. 3: COMMISSIONING AND WORK SHARING - Commissioning of Federal, State, and local officials, acceptance of 

a state’s commission, and work sharing initiatives. Ch. 4: ADVISORY ACTIONS - Procedures for Warning Letters and Untitled 

Letters. Ch. 5: ADMINISTRATIVE ACTIONS - Procedures for: Citation; Section 305 Meetings; Administrative Detention of 

Foods; Administrative Detention of Devices; License Revocation or Suspension; Orders for Retention, Recall, Destruction 

and Cessation of Manufacturing related to Human Cell, Tissue, and cellular and Tissue Based Products; and Civil Money 

Penalties. Ch. 6: JUDICIAL ACTIONS - Procedures for: Seizures; Injunctions; Inspection Warrants; Search Warrants; 

Prosecution; and Civil Penalties under Subchapter C of the Federal Food, Drug, and Cosmetic Act. Ch. 7: RECALL 

PROCEDURES - Procedures for Agency units to initiate, review, classify, publish, audit, and terminate recall actions. Ch. 8: 

EMERGENCY PROCEDURES - Emergency management procedures for FDA’s headquarters and field personnel. Ch. 9: 

IMPORT OPERATIONS/ACTIONS - Import procedures for articles subject to the laws and regulations enforced by the Food 

and Drug Administration. Ch. 10: OTHER PROCEDURES - Includes: Prior Notice; Regulatory Meetings; Establishment 

Inspection Report Conclusions and Decisions; Interstate Travel Program Classifications and Administrative Actions; 

Reporting and Monitoring; Ad Hoc Committees; the Appeal Process; Expert Support for Cases; Testimony; Production and 

Certification of Records; and the Application Integrity Policy. Ch. 11: GLOSSARY - Terms and Acronyms used in the RPM. 

Comment: Last updated 01-Oct-2010. 

Document date : Mar-2010 

Type of text : Manual 



USA - NIH Press Release: NIH Launches Genotype-Tissue Expression Project, 07- 

Oct-2010 

On October 07, 2010, the National Institutes of Health (NIH) announced the launch of a new project developed to have a 

more precise understanding of how genetic variation may control gene activity and its relationship to disease. This project, 

named the Genotype-Tissue Expression (GTEx), is a two-year pilot study supported by the NIH Common Fund. The purpose 

of this initiative is to create a resource researchers can use to study individual's susceptibility to complex human illnesses 

such as heart disease, cancer and diabetes. The project will also establish a tissue bank for future biological studies. 


Type of text : Press Release, Publication 



USA - Press Release: FDA Awards $904,000 to Pan American Health Organization 

for Information ‘Hub’, 06-Oct-2010 

This press release announces the award of a $904,000 cooperative agreement to the Pan American Health Organization 

(PAHO). This award is designed to help PAHO member states (38 countries in North, Central and South America, and the 

Caribbean) to develop an information "hub". The purpose of this hub is to better understand other countries' regulatory 

systems by collecting data in the areas of drugs, biologics, vaccines, medical devices and related regulatory processes and 

systems. 





USA - Press Release: FDA Awards Nearly $3 Million for TB Research, 04-Oct-2010 

This FDA press release announces the award of $2.9 million to support six research projects chosen from among 30 

applications that will help in the fight against tuberculosis (TB). Tuberculosis remains the second leading cause of infectious 

disease mortality (2-3 million deaths per year) in the world. Advances are urgently needed in TB drug development to 

shorten therapy and to treat drug-resistant disease. 





USA - Press Release: FDA Issues Regulatory Science Report, 06-Oct-2010 

This press release announces the publication of an FDA report entitled "Advancing Regulatory Science for Public Health" 

(114124). Regulatory science is the science of developing new tools, standards and approaches to assess the safety, 

efficacy, quality and performance of FDA-regulated products. This report discusses the role of the FDA, working with 

partners, to strengthen the field of regulatory science, both within the agency and throughout the Nation. 




Language : English

USA - Press Release: FDA Schedules Public Hearing on Biologics Price 

Competition and Innovation Act, 04-Oct-2010 

A two-day public hearing is scheduled on November 2-3, 2010 at the FDA’s White Oak Campus on the implementation of 

the Biologics Price Competition and Innovation (BPCI) Act of 2009. This hearing is hold to provide an opportunity for public 

participation and comment. The BPCI Act establishes an abbreviated approval pathway for biological products that are 

demonstrated to be highly similar (biosimilar) to, or interchangeable with, an FDA-licensed biological product. The FDA 

issued a Federal Register Notice to provide meeting information and outline specific issues for which the agency is seeking 

comment. 





USA - Questions and Answers: Critical Path 2010 Update, 2010 

The FDA issued this set of Questions & Answers to provide up-to-date information about the Critical Path Initiative (CPI) and 

describe the key achievements in the area of biomarker development and development of other tools, in the area of clinical 

trials work, and in the area of bioinformatics and safety. The document also presents the next steps and new efforts for 

Critical Path Initiative. 

Document date : 2010 




USA - Report: Advancing Regulatory Science for Public Health, Oct-2010 

This report on regulatory science was issued by the FDA on October 2010. It discusses how advances in regulatory science 

can speed progress in FDA’s high-priority public health areas. It is organized into two parts: the first one provides 

background on the emerging field of regulatory science, and explores seven different public health areas in which 

advancements in the field can help deliver more innovative products. The second section lays out a strategic framework that 

will guide FDA to advance regulatory science. 





USA - Report: The Critical Path Initiative: Report on Key Achievements in 2009, 

2010 

This report presents the Critical Path Initiative (CPI) successes and their significant public health outcomes, as well as a 

detailed look at some specific project areas. Launched in March 2004, the Critical Path Initiative is designed to narrow the 

gap between the number of discoveries occurring in biomedical science and technology and the declining number of new 

medical treatments submitted for FDA approval. 

Document date : 2010 




USA - Endocrinologic and Metabolic Drugs Advisory Committee (Slides / 

Handouts): The Sibutramine Cardiovascular Outcomes (SCOUT) Trial for New 

Drug Application (NDA) 20–632, Sibutramine Hydrochloride Monohydrate 

Capsules - Trade Name MERIDIA, for Treatment of Obesity, 15-Sep-2010 

On September 15, 2010, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) responded critically to the 

results of the Sibutramine Cardiovascular Outcomes (SCOUT) trial for Abbott Laboratories’ obesity drug Meridia (sibutramine 

hydrochloride), with half the committee members voting to support removal of the drug from the US market. Six other 

members voted to allow continued marketing of the drug with revised labeling, a boxed warning, and restricted distribution. 


Type of text : Slides 



USA - Speech: Remarks by Janet Woodcock, M.D. Director, Center for Drug 

Evaluation and Research - Decision on Continued Marketing of Rosiglitazone

(AVANDIA, AVANDAMET, AVANDARYL), 22-Sep-2010 

Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research, explains in this communication her decision to 

restrict the use of rosiglitazone due to data that suggest an elevated risk of cardiovascular events in patients treated with 

AVANDIA. While the European Medicines Agency (EMA) has decided to suspend marketing of rosiglitazone, the FDA has 

restricted patient access to the product and introduced new detailed patient information procedures. The agency hopes to 

obtain additional information to help further clarify the benefit-to-risk profile of the product should be received soon. 


Type of text : Speech 



USA - Hearing: Standards for Health IT: Meaningful Use and Beyond - House of 

Representative - Committee on Science and Technology, 30-Sep-2010 

On september 30, 2010 the Subcommitte of Technology and Innovation, held an hearing entitled "Standards for Health IT: 

Meaningful Use and Beyond". The purpose of the hearing was to examine the progress by the Department of Health and 

Human Services, the National Institute of Standards and Technology, and non-governmental health IT stakeholders in 

establishing standards for health IT, providing guidance for their implementation, and creating a mechanism to certify that 

health IT products comply with the established standards. This document contains the statements of: - Chairman David Wu 

- Dr. David Blumenthal (National Coordinator for Health Information Technology, DHHS) - Ms. Kathleen M. Roberts 

(Associate Director for Federal and Industrial Relations, National Institute of Standards and Technology) - Ms. Joyce 

Sensmeier (Vice President, Healthcare Information and Management Systems Society) - Dr. Dick Gibson (President, Oregon 

Health Network) - Ms. Deven McGraw (Director of the Health Privacy Project, Center for Democracy and Technology) - Ms. 

Deb Bass (President and CEO, Bass & Associates, Inc.) 


Type of text : Statement, Testimony 



USA - FDA Workshop (Transcript) 1/2: Issues in the Design and Conduct of 

Clinical Trials for Antibacterial Drug Development, 02-03-Aug-2010 

This document contains the transcript of a workshop entitled "Issues in the Design and Conduct of Clinical Trials for 

Antibacterial Drug Development" held on August 02 and 03, 2010. The purpose of the workshop was to provide information 

for and gain perspectives from health care providers, researchers, and regulators on various aspects of design and conduct 

of clinical trials for antibacterial drugs. 

Comment: This document is the transcript of the day one session, please see 113968 for the day two session. 


Type of text : Transcript 



USA - FDA Workshop (Transcript) 2/2: Issues in the Design and Conduct of 

Clinical Trials for Antibacterial Drug Development, 02-03-Aug-2010 

This document contains the transcript of a workshop entitled "Issues in the Design and Conduct of Clinical Trials for 

Antibacterial Drug Development" held on August 02 and 03, 2010. The purpose of the workshop was to provide information 

for and gain perspectives from health care providers, researchers, and regulators on various aspects of design and conduct 

of clinical trials for antibacterial drugs. 

Comment: This document is the transcript of the day two session, please see 113968 for the day one session. 


Type of text : Transcript 



Vietnam 

Vietnam - Circular: Guide and Inspection for the Implementation of Provision of 

State Management of Pharmaceuticals and Cosmetics, 7-Sep-2010 

This circular contains the guides and inspection activity for the implementation of regulation of state management for 

pharmacy and cosmetics. This guide covers management of addictive drug, psychotropics and precursors, drug quality 

management, management of drug price, drug information for advertisement, pharmacy trading, drug registration, drug 

bidding and supply, cosmetic management. This circular takes effect 45 days after the signing date. It supersedes decision 

no.2163/2001/QD-BYT dated on 8/June/2001 of MOH Minister on issuing “Stipulation on the inspection system of pharmacy 

activity at provinces, cities under authority central government”. There are 4 chapters in this circular: Chapter I: General

provision Chapter II: Inspection activity Chapter III: Performance Chapter IV: Implementation provision 


Type of text : Circular 


Language : Vietnamese 

Vietnam - Circular: Stipulation of the Management of Scientific Research and 

Experimental Production Project by MOH, 13-Aug-2010 

This circular stipulates the regulations of scientific research and experimental production project by MOH. The regulations 

include definition of research, recruitment for selection, evaluation, signing contract of scientific technology, inspection, 

acceptance, recognition and contract liquidation of experimental production project/theme at MOH. This research concerns 

drug experiment and clinical trial of medical equipment. The theme shall be subject to current legal regulation of clinical trial 

of drug and medical equipment and regulation of this circular. There are 8 chapters in this circular: Chapter I: General 

provision Chapter II: Definition of experimental production project/theme Chapter III: Recruitment for selection, selection of 

organization, individual to be in charge of trial production project/theme. Chapter IV: Inspection and performance provision 

Chapter V: Acceptance of trial production project/theme Chapter VI: Submit, publish and possess results of trial production 

project/theme Chapter VII: Executive Organization Chapter VIII: Implementation provision 


Type of text : Circular 


Language : Vietnamese 

For more information, please visit http://scientific.thomsonreuters.com 

Copyright ©2010 Thomson Reuters 

All Rights Reserved. 

Copying, reproduction, retransmission, or redistribution, including by framing or similar means of 

any material contained in the DIA Global Regulatory Activity Digest in whole or in part or in 

any medium or form is prohibited without express permission. 

Drug Information Association, 800 Enterprise Road, Suite 200, Horsham PA USA 19044.

Australia - Drug Information Association

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