NEW TEXTS THIS WEEK - Drug Information Association

In our effort to provide you with regulatory updates from around the world, DIA has
licensed this content from Thomson, parent of the IDRAC regulatory database. Please note
that due to implementation of changes to the IDRAC website, there were no DIA
Global Regulatory Activity Digests delivered the weeks of May 22 and May 29,
2007.
*** NEW TEXTS THIS WEEK ***
From Monday, 21-May-2007 to Friday, 01-Jun-2007
Documents available in IDRAC as of Wednesday, 06-Jun-2007.
ARGENTINA
Argentina - Disposition 2928/2007: Implementation of Resolution GMC 69/2006,
22-May-2007
From the date of coming into force of this Disposition it is not necessary to exchange
quarterly information on narcotics and psychotropics among MERCOSUR Members.
AUSTRALIA
Australia - Australian Regulation of Prescription Medicinal Products, May-2007
The Therapeutic Goods Act (30789) requires that medicinal products to be imported into,
supplied in, or exported from Australia be included in the Australian Register of Therapeutic
Goods (ARTG). In order for a product to be included in the ARTG, a sponsoring company is
required to make an application which usually consists of a form accompanied ... (Abstract
truncated to see more please, go to the document!)
Australia - Medical Device Incident Reports: 01/01/2007-31-03-2007
During the period from 01-Jan-2007 to 31-Mar-2007, the TGA has received 206 medical
device incident reports. In this document they are sorted by cause of problem, effect,
source category and result of investigation.
Australia - Medicine Recall: COMPLETE MoisturePlus Contact Lens Solution, 28-
May-2007
The company Advanced Medical Optics Australia Pty Ltd recalls all batches of COMPLETE
MoisturePlus contact lens solution because of reports of a rare, but serious, eye infection,
Acanthamoeba keratitis, caused by a parasite.
Australia - Newsletter: Australian Adverse Drug Reactions (ADRAC) Bulletin,
Vol.25, No.6, Dec-2006
This Australian Adverse Drug Reactions Bulletin covers the following topics: - Drug induced
pancreatitis - Leflunomide and interstitial lung disease - Tumour necrosis factor alpha
inhibitors - Subscribe to the bulletin on-line
AUSTRIA
Austria - Federal Office For Health Care Safety : Safety Information of 03-May-
2007 On Myocardial Disease Related To Salbutamol
The Federal Office For Health Care Safety informs of important changes affecting the safety
information of salbutamol-containing medicinal products, authorised in respiratory indication

(relief of bronchospasm in asthma conditions) but not in obstetrics indication in Austria.
Basically, the use of salbutamol in patients presenting a risk or diagnosed ... (Abstract
truncated to see more please, go to the document!)
Austria - Federal Office For Health Care Safety: Safety Information of 04-Apr-2007
On Occurrence of Fractures In Female Patients Receiving Pioglitazone-containing
Medicinal Products Long-Term Treatment (Clinical Trial Data Review)
Pioglitazone is indicated in the treatment of type 2 diabetes mellitus as monotherapy, dual
oral therapy or triple oral therapy in combination with metformin or/and a sulphonylurea in
particularly overweight patients with conditions defined in this document. Pioglitazone is
also indicated in combination with insulin in the treatment of type 2 diabetes ... (Abstract
truncated to see more please, go to the document!)
BELGIUM
Belgium - Royal Order of 27-Apr-2007: Fees to be Paid in Application of Article 30,
§6 of the Law of 07-May-2004 on Experiments on Human Beings (Dutch and
French versions)
This Royal Order defines the different fees to be paid to the Federal Agency for Medicines
and Health Products in the frame of the Article 30, § 6 of the law of 07 May 2004 relating to
clinical trials on human beings (48267).
BRAZIL
Brazil - Order 1.052: Approves the Master Plan (Plano Director) of the Brazilian
Sanitary Surveillance Sytem, 08-May-2007
The Plan covers the following matters (called Axis - Eixos) EIXO I: Organization and
management of the Brazilian Sanitary Surveillance System in the ambit of the SUS
(Organização e gestão do sistema nacional de vigilância sanitária no âmbito do SUS) EIXO
II: Regulatory action: surveillance of products, services and environment (ação regulatória:
... (Abstract truncated to see more please, go to the document!)
Brazil - Resolution RDC 29: Marketing Authorization Procedure to be followed for
the Replacement of the Infusion Systems in Large Volume Parenteral Solutions,
17-Apr-2007
This Resolution establishes the marketing authorization procedure to be followed for the
replacement of the open infusion system to the closed one, in large volume parenterals.
From 13-Mar-2008, it will be no longer allowed the applications for registration of opened
infusions systems For this reason marketing authorization holders of large volume ...
(Abstract truncated to see more please, go to the document!)
BULGARIA
Bulgaria - BDA Announcement: Important Information to All Manufacturers and
Wholesalers of Medicinal Product, 26-Apr-2007
All producers and wholesalers of medicinal products shall be obliged to submit to BDA
notifications for medicinal products and active substances supplied to this country (art. 207,
paragraph 1, item 7 and 8 and in connection with art. 208 of the drug law (LMPHM) -
(65217). The adequate form is provided in the annex to this document. The ... (Abstract
truncated to see more please, go to the document!)
CANADA
Canada - Dear Doctor Letter: Recent Reports of Black Particles after Reconstitution
of MYOZYME, 03-May-2007

Genzyme has received isolated complaints pertaining to an observation of black gelatinous
particles after reconstitution of 50 mg vials of MYOZYME (alglucosidase alfa). Working in
close consultation with relevant regulatory authorities, Genzyme immediately initiated an
investigation and discovered that when certain types of needles are used to penetrate ...
(Abstract truncated to see more please, go to the document!)
Canada - Dear Doctor Letter: Urgent - Voluntary Type I Recall of ratio-Valproic
(valproic acid) 500-mg Enteric-Coated Capsules in Canada, 11-May-2007
ratiopharm inc. is advising health care professionals of the immediate voluntary recall of all
lots of ratio-Valproic (valproic acid) 500-mg enteric-coated capsules (DIN 02140055)due to
stability test failures: routine stability testing has indicated that the product's shelf life is not
as long as marked on the packaging. As a result, a lesser amount ... (Abstract truncated to
see more please, go to the document!)
Canada - Dear Doctor Letter: Urgent Product Notification: One Touch Ultra Test
Strips, 30-Apr-2007
This Dear Doctor Letter informs health care professionals that a very small number of One
Touch Ultra Test Strip vials may contain a hole on the side. This king of damage to the vial
can affect the test strips inside and lead to error messages or blood glucose reults that are
too high or too low.
Canada - Dear Doctor Letter: Urgent-Voluntary Type I Recall of DEPAKENE
(valproic acid) 500 mg Enteric-Coated Capsules in Canada, 11-May-2007
Abbott Laboratories, Limited (Abbott) is advising health care professionals of the immediate
voluntary recall of all lots of DEPAKENE (valproic acid)500 mg enteric-coated capsules (DIN
00507989) due to stability test failures: routine stability testing has indicated that the
product's shelf life is not as long as marked on the packaging. As a result, ... (Abstract
truncated to see more please, go to the document!)
Canada - Expert Advisory Committee on Blood Regulation: Record of
Teleconference Meeting, 06-Jul-2006
The following topics were discussed during this meeting: - Autologous Tissue Donation
Update - Summary of comments received on the CTO regulations -
Decisions/recommendations of EAC-CTO on BGTD's position on classification of minimallymanipulated
islet cells - Recipient notification in cases where the recipient has received a
non-compliant CTO - update on tissue recall issue
Canada - Expert Advisory Committee on Blood Regulation: Record of
Teleconference Meeting, 06-Oct-2006
The following topics were discussed during this meeting: - West Nile Virus (WNV) Donor
Deferral - Simian Foamy Virus
Canada - Fact Sheet: Therapeutic Products Directorate: Good Review Practices
Project, 08-May-2007
This fact sheet clarifies the Good Review Practices Project, launched by the Therapeutic
Products Directorate on 01-Mar-2004.
Canada - Form: Application Form for Custom-Made Devices and Medical Devices for
Special Access, May-2007
This form is to be filled in by health care professionals for custom-made devices and medical
devices for special access.
Canada - Instructions for Completing the Application Form for Custom-Made

Devices and Medical Devices for Special Access, May-2007
This document has been prepared to assist health care professionals to complete the
Application Form for Custom-Made Devices and Medical Devices for Special Access (70134).
The requirements for Special Access can be found under Part 2, Sections 69-78 of the
Medical Devices Regulations (47294).
Canada - NHPD Monograph: Tea, 09-May-2007
Description of the Monograph tea. The Monograph contains 11 elements, as follows: -
proper name(s) - common name(s) - source material(s) - route(s) of administration -
dosage form(s) - use(s) or purpose(s) - dose(s) - duration of use - risk information - nonmedicinal
ingredients - specifications
Canada - Notice of Decision: SPRYCEL (dasatinib), 09-May-2007
On March 26, 2007, Health Canada issued a Notice of Compliance under the Notice of
Compliance with Conditions (NOC/c) Policy to Bristol-Myers Squibb Canada for the drug
product Sprycel. The product was authorized under the NOC/c Policy on the basis of the
promising nature of the clinical evidence, and the need for confirmatory studies to verify ...
(Abstract truncated to see more please, go to the document!)
Canada - Pharmaceutical Sciences: Questions and Answers, 23-May-2007
This document is intended to provide clarification on a number of issues that relate to
Quality (e.g. Chemistry and Manufacturing) and Biopharmaceutics
(e.g.,Bioequivalence/Bioavailability) information of human drug submissions for
pharmaceutical-type products. It is based on the current thinking on the topic. They are
intended to briefly communicate ... (Abstract truncated to see more please, go to the
document!)
Canada - Product Monograph Part III: ORENCIA (abatacept) - (Consumer
Information), 29-Jun-2006
The Consumer Information Section (Part III) of the Product Monograph for ORENCIA
(abatacept) has been submitted by the drug sponsor. The attached version accompanied
the Notice of Compliance issued on 29-Jun-2006 and does not necessarily reflect the most
current information for the product.
Canada - Regulations: Amending the Food and Drug Regulations (1434 - Schedule
F), 26-Apr-2007
This amendment adds ten medicinal ingredients to Part I of Schedule F to the Food and
Drug Regulations (24027): - agalsidase alfa - botulinum toxin Type B - laronidase -
miglustat - muromonab - CD 3 - pegfilgrastim - pemetrexed and its salts - rasburicase -
teriparatide and its salts - vardenafil and its salts
Canada - Rules Amending the Patent Rules, 03-May-2007
The amendments to the Patent Rules deal with: a) the small entity regime; b) the
harmonization of the Canadian standard for describing sequence listing with the Patent
Cooperation Treaty (PCT) standard; c) the type of evidence required when the applicant is
not the inventor; d) the refund policy; e) the clarification of certain practices for PCT
national ... (Abstract truncated to see more please, go to the document!)
Canada - Summary Basis of Decision (SBD): RAPTIVA (efalizumab), 15-May-2007
On October 24, 2005, Health Canada issued a Notice of Compliance to Serono Canada Inc.
for the drug product Raptiva. Raptiva contains the medicinal ingredient efalizumab, a
recombinant humanized monoclonal immunoglobulin G1 (IgG1) antibody with
immunomodulatory properties. Raptiva is indicated for the treatment of moderate to severe

chronic plaque ... (Abstract truncated to see more please, go to the document!)
CZECH REPUBLIC
Czech Republic - SUKL: Monthly Regulatory Update No 04, Apr-2007
This document lays down the most important regulatory news occured in the Czech
Republic. Most important news for Apr-2007: -Safety review of Epoetins by EMEA -
Publication of a Guideline on Packaging of pharmaceuticals
Czech Republic - Vestnik SUKL No 05, May-2007
Content of the SUKL's Bulletin (Vestnik SUKL) 05/2007.
EUROPEAN UNION
European Union - CHMP Positive Opinion EMEA/CHMP/108222/2007: Granting of a
Marketing Authorization for OPTIMARK (gadoversetamide), 24-May-2007
This document provides the CHMP Positive Opinion for the granting of a marketing
authorisation for the medicinal product OptiMARK (gadoversetamide). - Applicant: Tyco
Healthcare Deutschland GmbH. - Indications: diagnosis of focal lesions and abnormal
structures in the Central Nervous System (CNS) and liver. The CHMP, on the basis of
quality, safety ... (Abstract truncated to see more please, go to the document!)
European Union - CHMP Positive Opinion EMEA/CHMP/154613/2007: Granting of a
Marketing Authorization for AERINAZE (desloratidine, pseudoephedrine sulphate),
24-May-2007
This document provides the CHMP Positive Opinion for the granting of a marketing
authorisation for the medicinal product AERINAZE (desloratidine, pseudoephedrine
sulphate). - Applicant: Schering-Plough Europe. - Indications: symptomatic treatment of
allergic rhinitis. The CHMP, on the basis of quality, safety and efficacy data submitted,
considers ... (Abstract truncated to see more please, go to the document!)
European Union - CHMP Positive Opinion EMEA/CHMP/201677/2007: Granting of a
Marketing Authorization for INCRELEX (mecasermin), 24-May-2007
This document provides the CHMP Positive Opinion for the granting of a marketing
authorisation for the medicinal product INCRELEX (mecasermin). - Applicant: Tercica Europe
Ltd. - Indications: long-term treatment of growth failure in children and adolescents with
severe primary insulin-like growth factor-1 deficiency (Primary IGFD) or with growth ...
(Abstract truncated to see more please, go to the document!)
European Union - CHMP Positive Opinion EMEA/CHMP/219213/2007: Post-
Authorisation Summary of Opinion for FORSTEO (teriparatide), 24-May-2007
This document provides the CHMP Post-Authorisation Summary of Opinion for the medicinal
product FORSTEO (teriparatide). - Applicant: Eli Lilly Nederland B.V. - The CHMP adopted a
change to the therapeutic indication.
European Union - CHMP Positive Opinion EMEA/CHMP/219942/2007: Granting of a
Marketing Authorization for ORLISTAT GSK (orlistat), 24-May-2007
This document provides the CHMP Positive Opinion for the granting of a marketing
authorisation for the medicinal product ORLISTAT GSK (orlistat). - Applicant: Glaxo Group
Ltd trading as GlaxoSmithKline Consumer Healthcare. - Indications: for treatment, in
conjunction with a mildly hypocaloric diet, of obese patients with a body mass index greater
... (Abstract truncated to see more please, go to the document!)
European Union - CHMP Positive Opinion EMEA/CHMP/219954/2007: Post-

Authorisation Summary of Opinion for PLAVIX (clopidogrel), 24-May-2007
This document provides the CHMP Post-Authorisation Summary of Opinion for the medicinal
product PLAVIX (clopidogrel). - Applicant: Sanofi Pharma Bristol-Myers squibb SNC. - The
CHMP adopted a change to the wording of the Non-ST segment elevation acute coronary
syndrome (NSTEACS) indication.
European Union - CHMP Positive Opinion EMEA/CHMP/219959/2007: Post-
Authorisation Summary of Opinion for ISCOVER (clopidogrel), 24-May-2007
This document provides the CHMP Post-Authorisation Summary of Opinion for the medicinal
product ISCOVER (clopidogrel). - Applicant: Bristol-Myers Squibb Pharma EEIG. - The CHMP
adopted a change to the wording of the Non-ST segment elevation acute coronary
syndrome (NSTEACS) indication.
European Union - CHMP Positive Opinion EMEA/CHMP/221909/2007: Granting of a
Marketing Authorization for MIRCERA (methoxy polyethylene glycol-epoetin beta),
24-May-2007
This document provides the CHMP Positive Opinion for the granting of a marketing
authorisation for the medicinal product MIRCERA (methoxy polyethylene glycol-epoetin
beta). - Applicant: Roche Registration Ltd - Indications: treatment of anaemia associated
with chronic kidney disease. The CHMP, on the basis of quality, safety and efficacy data ...
(Abstract truncated to see more please, go to the document!)
European Union - CHMP Positive Opinion EMEA/CHMP/228662/2007: Post-
Authorisation Summary of Opinion for SUSTIVA (efavirenz), 24-May-2007
This document provides the CHMP Post-Authorisation Summary of Opinion for the medicinal
product SUSTIVA (efavirenz). - Applicant: Bristol-Myers Squibb Pharma EEIG. - The contraindication
beween efavirenz and voriconazole was removed since a recommendation on
dose adjustements was agreed by the CHMP.
European Union - CHMP Positive Opinion EMEA/CHMP/228663/2007: Post-
Authorisation Summary of Opinion for STOCRIN (efavirenz), 24-May-2007
This document provides the CHMP Post-Authorisation Summary of Opinion for the medicinal
product STOCRIN (efavirenz). - Applicant: Merck Sharp & Dohme Ltd. - The contraindication
beween efavirenz and voriconazole was removed since a recommendation on
dose adjustements was agreed by the CHMP.
European Union - CHMP/ICH Draft Guideline EMEA/CHMP/ICH/214732/2007,
Topic Q10, Step 3: Pharmaceutical Quality System, May-2007
This Draft guideline has been released for consultation. This guideline describes one
comprehensive approach to an effective pharmaceutical quality system that is based on ISO
concepts, includes applicable Good Manufacturing Practice (GMP) regulations and
complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk
Management”. ICH ... (Abstract truncated to see more please, go to the document!)
European Union - Commission Draft Report: on the Experience Acquired as a
Result of the Application of the Provisions of Chapter éa of Directive 2001/83/EC
(introduced by Directive 2004/24/EC) on Specific Provisions Applicable to
Traditional Herbal Medicinal Products, May-2007
DG Enterprise and Industry launches a public consultation on a draft report on the
experience acquired as a result of the application of the provisions of Chapter 2a of
Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable
to traditional herbal medicinal products, as required under Article 16i of Directive
2001/83/EC.

European Union - EMEA COMP Press Release EMEA/COMP/244638/2007: Meeting
of the Committee for Orphan Medicinal Products, 01-Jun-2007
The Committee for Orphan Medicinal Products (COMP) held its 79th meeting on 30/31-May-
2007. The Committee adopted five positive opinions on orphan medicinal product
designation during this meeting. The COMP noted that three applications for orphan
medicinal product designation were withdrawn at evaluation. The European Commission
granted ... (Abstract truncated to see more please, go to the document!)
European Union - EMEA HMPC Press Release EMEA/HMPC/216295/2007: 17th
Meeting Report 08-May-2007 of the Committee for Herbal Medicinal Products
(HMPC), 21-May-2007
The Committee on Herbal Medicinal Products met for the 17th time at the EMEA offices on
DD08-May-2007. During this meeting, reports were established by MLWP, Organisational
Matters Drafting Goup and Quality Drafting Group.
European Union - EMEA Press Release EMEA/230057/2007: EMEA Statement on
Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet,
Avaglim), 23-May-2007
An article published in the New England Journal of Medicine (NEJM) has raised concern
about a small increased risk of myocardial infarction and cardiovascular death in patients
with type 2 diabetes treated with rosiglitazone. The article, based on an analysis of data
retrieved from 42 clinical studies, showed a small increased risk for myocardial infarction ...
(Abstract truncated to see more please, go to the document!)
European Union - EMEA Press Release EMEA/235491/2007: Protherics Withdraws
its Marketing Authorisation Application for Voraxaze, 29-May-2007
The European Medicines Agency (EMEA) has been formally notified by Protherics PLC of its
decision to withdraw the application for a centralised marketing authorisation for the
medicinal product Voraxaze (glucarpidase) powder for solution for injection 1000 Units.
European Union - EMEA/218760/2007: Questions and Answers on Bicalutamide
150 mg Tablets, 24-May-2007
Following a request from Belgium, the European Medicines Agency’s (EMEA’s) Committee for
Medicinal Products for Human Use (CHMP) has reviewed the available information on the
effectiveness and safety of medicines containing 150 mg bicalutamide, used orally (by
mouth) for the treatment of locally advanced prostate cancer.
European Union - EMEA/219924/2007: Questions and Answers on
Recommendation for the Refusal of the Marketing Authorisation for VECTIBIX
(panitumumab), 24-May-2007
This document is a Questions and Answers on Recommendation for Refusal of Marketing
Application for VECTIBIX (panitumumab). - Applicant: Amgen Europe B.V. - Indication:
treatment of metastatic carcinoma of the colon or rectum.
European Union - Pharmaceutical Committee: Summary Record of the 62nd
Meeting, 21-May-2007
The Pharmaceutical Committee held its 62nd meeting on 21-May-2007, in Brussels. This
meeting report intends to provide for public information a brief summary of the outcome on
the different topics on the agenda.
European Union - Summary of Community Decisions 2007/C 115/03: Marketing
Authorisations in Respect of Medicinal Products Related to the Centralised

Procedure from 01-Apr-2007 to 30-Apr-2007
- Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004):
Accepted for: TOVIAZ, Docetaxel, Winthrop, Advagraf, Sebivo - Modification of a marketing
authorization (Article 13 of Regulation (EC) No 726/2004): Accepted for: Dynepo, Prevenar,
Xigris, AZILECT, Enbrel, Cerezyme, Panretin, TARGRETIN, Infanrix Penta, Infanrix ...
(Abstract truncated to see more please, go to the document!)
FRANCE
France - AFSSAPS: List of Authorized Inspectors
This document provides the updated list of the authorized inspectors from the French
Agency for the Safety of Health Products (AFSSAPS). Last update: 15-May-2007 (B.O. n°
2007/4)
GERMANY
Germany - BfArM and PEI Joint Draft Recommendations on Planning, Conduction
and Assessment of Observational Studies, Version of 09-May-2007
These draft recommendations jointly published by BfArM and PEI intend to define the terms
Observational Study or Non Interventional Study taking into account both german and
international considerations. They also give recommendations to the following: - the content
of an observational / non interventional study plan, - the study design, - possible ...
(Abstract truncated to see more please, go to the document!)
Germany - BfArM: Desmopressin Nasal Spray and Risk of Hyponatraemia and
Water Intoxication; Removal Of the Indication "Primary Nocturnal Enuresis"
(PNE)- Status: 24-May-2007
The CHMP has decided the removal of the indication primary nocturnal enuresis for nasal
spray formulations of Desmopressin. Reason for this decision is a higher occurrence of
serious adverse drug reactions (hyponatraemia, water intoxication) related to the nasal
spray form in comparison to other pharmaceutical forms, which have been reported by a ...
(Abstract truncated to see more please, go to the document!)
Germany - BfArM Letter: Protection from Drug Risks, Hearing - Stage II - Delayedrelease
Oxycodone - 23-May-2007
The BfArM has set 01-Jul-2007 as a deadline for manufacturers to add information on
simultaneous intake of ethanol and oxycodone in sections 4.2 “Posology and method of
administration” (SPC and Package Leaflet) and 4.4 “Special warnings and precautions for
use” (SPC) of the product information of delayed-release oxycodone-containing medicinal
products ... (Abstract truncated to see more please, go to the document!)
Germany - BfArM Press Release 12/2007: BfArM Warns About Counterfeit
TAMIFLU Sold Through Internet - 15-May-2007
BfArM warns patients and consumers about potential risks of buying and taking Tamiflu sold
through the internet. Two recent cases of counterfeit have been reported. The two fake
medicinal products have been confiscated in South Korea, of which one had been bought
through the internet. After analyses, it appears that one of these products contains ...
(Abstract truncated to see more please, go to the document!)
INTERNATIONAL
International - ICH Guideline: Pharmaceutical Quality System (Topic Q 10, Step 2,
09-May-2007)
This guideline has been released for consultation on 09-May-2007 at Step 2 of the ICH
Process by the ICH Steering Committee. This document establishes a new ICH tripartite

guideline describing a model for an effective quality management system for the
pharmaceutical industry, referred to as the Pharmaceutical Quality System. ICH Q10
describes one ... (Abstract truncated to see more please, go to the document!)
ITALY
Italy - AIFA Pharmacovigilance Bulletin (Reazioni) N. 3/2007 (May-2007)
This document concerns the Pharmacovigilance Bulletin (Reazioni) Anno I - N. 3/2007
issued by the AIFA.
JAPAN
Japan - HPB Notification No. 0515003: Handling of Listing of Generic Medicinal
Products to the NHI Drug Price Standard, 15-May-2007 (English/Japanese
version)
The twice-a-year listing of generic medicinal products to the NHI Drug Price Standard was
agreed in the general meeting of the Central Social Insurance Medical Council held on 18th
April 2007. Based on this, the timing of listing of generic medicinal products and other
products in 2007 and other related matters are decided accordingly. The timing ... (Abstract
truncated to see more please, go to the document!)
Japan - PFSB/CND Notification No. 0516005: Handling of Overseas Manufacturing
Businesses While They are Regarded as Having Accreditations, 16-May-2007
(English/Japanese version)
This notification concerns the document to be submitted by importers when they are
examined to see if they have submitted the necessary information in accordance with Article
94 and Article 95 of the Pharmaceutical Affairs Law Enforcement Regulations. If a person
who imports a product from a business which is regarded as having received the
accreditation ... (Abstract truncated to see more please, go to the document!)
Japan - PFSB/ELD, PFSB/CND Notice: Schedules for Approval Reviews and GMP
Conformity Inspection Applications for Ethical Generic Medicinal Products Which
Have Been Submitted for New Marketing Approvals, 15-May-2007
(English/Japanese version)
November has been added as an opportunity for listing generic medicinal products and
other products to the NHI Drug Price Standard. Consequently MHLW re-scheduled approval
reviews, GMP conformity inspections of ethical generic medicinal products for which new
marketing approval applications have been filed before the end of July, 2006. Schedules ...
(Abstract truncated to see more please, go to the document!)
Japan - Q&A: PFSB/ELD, PFSB/CND Notice: Procedure of Change of Manufacturing
Site for the Medical Devices and In-vitro Diagnostic Products, 27-Apr-2007
(English/Japanese version)
This document presents the Q&A on Procedure of Change of Manufacturing Site for the
Medical Devices and In-vitro Diagnostic Products which was issued by PFSB/ELD Notification
No. 0330004, PFSB/CND Notification No. 0330012 on 30-Mar-2007 (64982).
POLAND
Poland - Law 07.75.492 of 30-Mar-2007: Amendment of the Pharmaceutical Law
and Amendment of Certain Other Laws
This law amends the pharmaceutical law significantly. The changes are far reaching and
pertain to clinical trials, registration, manufacture, advertising, wholesale and retail trade,
inspections and sanctions.

PORTUGAL
Portugal - Deliberation 105/CA/2007: Procedures for Special Use Authorisation
(AUE) and Exceptional Use Authorisation (AEX) of Medicinal Products, 01-Mar-
2007
In the framework of article 92, no. 2 and article 93, no. 7 of the Decree-Law 176/2006
dated 20-Aug-2006 (60520), the INFARMED approves the regulation - appended to this
Deliberation - on the Special Use Authorisation (AUE) (also called Compassionate Use) and
Exceptional Use Authorisation (AEX) of medicinal products. This Regulation lays down ...
(Abstract truncated to see more please, go to the document!)
Portugal - INFARMED Form: Compulsory Template to Applicants for a Special Use
Authorisation (AUE) of Medicinal Products for Human Use
This document is available in a ready-to-use format. In accordance with the article 92,
paragraph a) of the Decree-Law 176/2006 (60520), and Deliberation 105/CA/2007 (70057),
this form should be used for obtaining a special use authorisation (compassionate use) for
patients who need treatment with medicinal products non-authorised in Portugal.
Portugal - INFARMED Form: Special Use Authorisation (AUE) - Clinical Justification
This document is available in a ready-to-use format. In accordance with the article 92,
paragraph a) of the Decree-Law 176/2006 (60520) and Deliberation 105/CA/2007 (70057),
this form should be used to justify the clinical and therapeutic benefit of a medicinal
product, in addition to the application form (70109) for obtaining ... (Abstract truncated to
see more please, go to the document!)
Portugal - INFARMED: Guidance Notes for the Submission of Special Use
Authorisation (AUE) Application of Industrially Manufactured Allergens
The INFARMED is clarifying the situation regarding allergen-containing products which
require, as for all medicinal products, a marketing authorisation application. These Guidance
Notes specify the documentation required for the application submission of Special Use
Authorisation (AUE) of allergen-containing products. This document is written in accordance
... (Abstract truncated to see more please, go to the document!)
Portugal - INFARMED Information Circular 054/CD (19-Apr-2007): salbutamol and
Risk of Myocardial Ischemia - New Safety Data
Safety Information. The INFARMED wants to draw the attention to the important changes
that have been performed on the safety information of medicinal products containing
salbutamol, used as well in obstetrics indication as in respiratory indication. Basically, in
both indications, the use of salbutamol is contra-indicated in patients presenting a ...
(Abstract truncated to see more please, go to the document!)
Portugal - INFARMED Information Circular 056/CD (03-May-2007): Epoetins -
Revision of Safety Information
Safety Information. The INFARMED informs that the safety of all epoetins is being evaluated
at European level following publications of new data (published or unpublished studies),
revealing an increased risk of serious cardiovascular complications in patients with cronic
renal insufficiency and a possible effect of tumor progression in cancer patients. Epoetins ...
(Abstract truncated to see more please, go to the document!)
Portugal - INFARMED Information Circular 062/CD (18-May-2007): nimesulide -
Safety Information
Safety Information. Nimesulide is an NSAID with analgesic action approved since 1985.

Although the risk of hepatic ADR occurrences with the administration of nimesulide is
known, the EMEA evaluations demonstrated a positive benefit-risk balance provided a close
respect of the SPC and PL which contraindicate the treatment with nimesulide in patients ...
(Abstract truncated to see more please, go to the document!)
Portugal - INFARMED Information Circular 065/CA (22-May-2007): rosiglitazone
Safety Information. The INFARMED wishes to inform on the FDA alert on medicinal products
containing rosiglitazone following a study published in the "New England Journal of
Medicine" relative to the cardiovascular safety with rosiglitazone. This active ingredient is
approved in the European Union through centralised procedure under the trade name ...
(Abstract truncated to see more please, go to the document!)
ROMANIA
Romania - NMA News: To the Attention of Clinical Trial Sponsors, 11-May-2007
(Romanian and English Versions)
This document describes the admission by the NMA of applications for clinical trial approval
and accompanying dossier, as of 01-Jun-2007.
Romania - NMA News: To the Attention of Marketing Authorisation Holders for
Biological Products, 17-May-2007 (Romanian and English Versions)
Placing on the Romanian market requires filling in the form regarding NMA notification on
the intention to market a batch of biological product for human use in Romania, according
to Annex A to this document. Marketing authorisation holders for biological products
manufactured in third countries, in addition to filling in the above mentioned form, ...
(Abstract truncated to see more please, go to the document!)
SOUTH KOREA
South Korea - KFDA Notification No. 2006-53: Amendment of Provisions on
Application for Review of Specification & Testing Methods of Pharmaceutical
Drugs, 29-Nov-2006 (English/Korean version)
This notification presents the amendments of Provisions on Application for Review of
Specification & Testing Methods of Pharmaceutical Drugs (59752). The amendmends are
made in the article 8, 24, Annex 4, 5 and 8.
South Korea - KFDA Notification No. 2007-14: Amendment of Notification
Regarding Stability Data, 19-Mar-2007 (English/Korean version)
This notification presents the amendements of Notification Regarding Stability Data which
was issued on 27-Dec-2006 (63628). The amendements concerns the article 4.
South Korea - KFDA Notification No. 2007-4: Amendment of Guidelines for
Management of Clinical Trials of Pharmaceutical Drugs, 19-Jan-2007
(English/Korean version)
This notification presents the amendments of Guidelines for Management of Clinical Trials of
Pharmaceutical Drugs (59758)
SPAIN
Spain - Royal Decree 618/2007: Procedures for Creating Particular Reserves to
Specific Conditions of Prescription and Supply of Medicinal Products, 11-May-2007
In accordance with the Article 89 of Law 29/2006 (59875), the specific conditions of
prescription and supply of medicinal products can be subject to the creation of particular
reserves within the intended goal. The requirements and conditions for the creation of such
reserves is described in this document. The objective of particular reserves ... (Abstract

truncated to see more please, go to the document!)
SWITZERLAND
Switzerland - Swissmedic Communication: Countries from which a registered
medicinal product may be imported according to article 14, section 2 of the LTP /
actualization, Apr-2007
According to article 28, section 2 of the Ordinance on the simplified registration of medicinal
products and the registration of medicinal products subject to notification Swissmedic
informs about the countries having an equivalent registration system in the sense of article
14, section 2 of the LTP. In Swissmedic Journal of March 2002 (page 107) a ... (Abstract
truncated to see more please, go to the document!)
TAIWAN
Taiwan - Announcement: Death Follow Up Sheet for Pharmaceutical Clinical Study,
18-May-2007 (Taiwanese version)
1. To improve the safety of subjects who participate in clinical practice, sponsors should
report to the regulatory authority based on the Good Clinical Practice (GCP) and fill out the
“Death follow up sheet for pharmaceutical clinical study” and still report to the Taiwan Drug
Relief Foundation, National Spontaneous ADR Reporting System when a death ... (Abstract
truncated to see more please, go to the document!)
Taiwan - Announcement: Qualifications of Principal Investigator of Clinical Study,
18-May-2007 (Taiwanese version)
1. The Department of Health announced that the “Qualifications and abilities of Principal
Investigator should fit in with government’s regulations and have appropriate experience to
implement clinical studies” in accordance with Article 30 of the “Good Clinical Practice
(GCP)” which was issued on 06 January 2005, issue number 0930338510. 2. The
qualifications ... (Abstract truncated to see more please, go to the document!)
UNITED KINGDOM
United Kingdom - MAIL 161 May/June 2007
This issue covers the following topics: - Clarification of the fee applicable for product licence
applications and variations which are eCTD compliant - MHRA grants first registrations
under the Traditional Herbal Medicines Registration Scheme
United Kingdom - MHRA: Consolidated Guidance on Transitional Arrangements for
the Directive on Traditional Herbal Medicinal Products (Directive 2004/21/EC,
Amending Directive 2001/83/EC), May-2006
This consolidated guidance has been developed in response to a number of queries received
by the MHRA about the end of transitional protection under the Directive on traditional
herbal medicinal products. Please note that this guidance represents MHRA’s view and
cannot be taken to be a definitive statement of the law. This can only be given by the ...
(Abstract truncated to see more please, go to the document!)
United Kingdom - MHRA: Guidance on the Use of Non-GLP Compliant Facilities for
the Conduct of Study Phases, May-2007
This guidance only applies to the use of test facilities that have a permanent physical
presence. It is recognised that field trials can present particular challenges and more
specific guidance is at Appendix 1.
United Kingdom - MHRA: Statutory Pharmacovigilance Inspection - Summary of
Pharmacovigilance (SPS) Document, Apr-2007

This document provides information to assist companies with the preparation of the
Summary of Pharmacovigilance Systems (SPS). The SPS is an invaluable tool used by the
Pharmacovigilance Inspectorate of the MHRA to aid planning and preparation for a
forthcoming pharmacovigilance system inspection. Following the inspection, companies
should view ... (Abstract truncated to see more please, go to the document!)
USA
USA - AdComm Profiles: Biography of Judith Kramer, MD, MS - Member of the Drug
Safety and Risk Management Advisory Committee, 10/24/2006 - 05/31/2010
This document contains the biography of Judith Kramer, MD, MS, Member of the Drug
Safety and Risk Management Advisory Committee for the period 10/24/2006 - 05/31/2010.
USA - AdComm Profiles: Biography of Sander Greenland, Dr., PhD - Member of the
Drug Safety and Risk Management Advisory Committee, 06/01/2006 -
05/31/2010
This document contains the biography of Sander Greenland, Dr., PhD - Member of the Drug
Safety and Risk Management Advisory Committee, 06/01/2006 - 05/31/2010.
USA - AdComm Profiles: Biography of Sean Hennessey, PharmD, PhD - Member of
the Drug Safety and Risk Management Advisory Committee, 10/24/2006 -
05/31/2009
This document contains the biography of Sean Hennessey, PharmD, PhD, Member of the
Drug Safety and Risk Management Advisory Committee for the period 10/24/2006 -
05/31/2009
USA - AdComm Profiles: Biography of Susan R. Heckbert, MD, PhD - Member of the
Drug Safety and Risk Management Advisory Committee, 10/24/2006 -
05/31/2010
This document contains the biography of Susan R. Heckbert, MD, PhD, Member of the Drug
Safety and Risk Management Advisory Committee for the period 10/24/2006 - 05/31/2010.
USA - AdComm Profiles: Biography of Timothy S. Lesar, PharmD - Member of the
Drug Safety and Risk Management Advisory Committee, 10/24/2006 -
05/31/2009
This document contains the biography of Timothy S. Lesar, PharmD, Member of the Drug
Safety and Risk Management Advisory Committee for the period 10/24/2006 - 05/31/2009.
USA - AdComm Voting: Voting History of Pankaj. J. Pasricha - Member of the
Gastrointestinal Drugs Advisory Committee, 09/27/2005 - 06/30/2009
This document contains the voting history of Pankaj. J. Pasricha, Member of the
Gastrointestinal Drugs Advisory Committee for the period 09/27/2005 - 06/30/2009.
USA - AdComm Voting: Voting History of Sean Hennessey, PharmD, PhD - Member
of the Drug Safety and Risk Management Advisory Committee, 10/24/2006 -
05/31/2009
This document contains the voting history of Sean Hennessey, PharmD, PhD, Member of the
Drug Safety and Risk Management Advisory Committee for the period 10/24/2006 -
05/31/2009
USA - Biologics License Application (BLA) (Supplemental Approval): EPOGEN,
PROCRIT (epoetin alfa) - Approval Letter and Labeling, 09-Mar-2007
This biologics license application supplement, BLA 103234/5122, provides for the use of

PROCRIT and EPOGEN (epoetin alfa), for the treatment of anemia associated with CRF,
including patients on dialysis (ESRD) and patients not on dialysis, for the treatment of
anemia related to therapy with zidovudine in HIV-infected patients, for the treatment of ...
(Abstract truncated to see more please, go to the document!)
USA - CEPH International Corporation, 21-Mar-22-Apr-2005: FDA 483
This 3-pages form FDA 483 was issued at the conclusion of an inspection of drug
manufacturer CEPH International Corporation in Carolina, Puerto Rico. The following
observations were reported: - Control procedures are not established which monitor the
output and validate the performance of those manufacturing processes that may be
responsible for causing ... (Abstract truncated to see more please, go to the document!)
USA - Congressional Testimony: Statement of Donald Mattison, M.D. (National
Institutes of Health) - "Programs Affecting Safety and Innovation in Pediatric
Therapies", 22-May-2007
This hearing was held by the U.S. House of Representatives Committee on Energy and
Commerce's subcommittee on Health. In this testimony, Dr. Donald Mattison, Chief of
Obstetric and Pediatric Pharmacology Branch at NIH's National Institute of Child Health and
Human Development, discusses NIH's research activities in relation to implementation of
the ... (Abstract truncated to see more please, go to the document!)
USA - Congressional Testimony: Statement of Lori M. Reilly (Pharmaceutical
Research and Manufacturers of America) - "Programs Affecting Safety and
Innovation in Pediatric Therapies", 22-May-2007
This hearing was held by the U.S. House of Representatives Committee on Energy and
Commerce's subcommittee on Health. In this testimony, Lori Reilly, PhRMA's Vice President
of Policy & Research, discusses the following topics: - the pediatric exclusivity program -
pediatric studies conducted over the last 10 years. - the most frequently studied ...
(Abstract truncated to see more please, go to the document!)
USA - Congressional Testimony: Statement of Peter Lurie, M.D., M.P.H. (Public
Citizen's Health Research Group) - "Programs Affecting Safety and Innovation in
Pediatric Therapies", 22-May-2007
This hearing was held by the U.S. House of Representatives Committee on Energy and
Commerce's subcommittee on Health. In this testimony, Dr. Peter Lurie, Deputy Director of
Public Citizen's Health Research Group, discusses the following topics: - how to ensure that
studies of pediatric drugs and biologics are indeed conducted - issues surrounding ...
(Abstract truncated to see more please, go to the document!)
USA - Congressional Testimony: Statement of Robert Essner (Wyeth) -
"Alzheimer's Disease: Current and Future Breakthrough Research", 15-May-2007
On May 15, 2007, the U.S. Senate Committee on Health, Education, Labor and Pensions'
subcommittee on Aging and Retirement held a hearing on the subject of breakthrough
research on Alzheimer's disease. In this testimony, Robert Essner, Wyeth's Chairman and
Chief Executive Officer, testifies on how the private sector is trying to harness science to
overcome Alzheimer's disease.
USA - Congressional Testimony: Statement of Sandra Lynn Kweder, M.D. (Food
and Drug Administration) - "Programs Affecting Safety and Innovation in Pediatric
Therapies", 22-May-2007
This hearing was held by the U.S. House of Representatives Committee on Energy and
Commerce's subcommittee on Health. In this testimony, Rear Admiral Sandra Kweder,
Deputy Director of CDER's Office of New Drugs, discusses FDA's role with respect to

implementation of the Best Pharmaceuticals for Children Act and the Pediatric Research
Equity Act.
USA - Curriculum Vitae (CV) of Sander Greenland, Dr., PhD - Member of the Drug
Safety and Risk Management Advisory Committee for the period 2006-2010
This document contains the Curriculum Vitae (CV) of Sander Greenland, Dr., PhD - Member
of the Drug Safety and Risk Management Advisory Committee for the period 2006-2010
USA - Draft Guidance for Industry and Review Staff: Labeling for Human
Prescription Drugs - Determining Established Pharmacologic Class for Use in the
Highlights of Prescribing Information, May-2007
This guidance is intended to help applicants and the review staff in the Center for Drug
Evaluation and Research (CDER) at the Food and Drug Administration (FDA) determine
when a drug belongs to an established pharmacologic class as well as how to select the
appropriate word or phrase (term) that describes the pharmacologic class for inclusion in
the ... (Abstract truncated to see more please, go to the document!)
USA - Drug Approval Package: NEUPRO (rotigotine) - Approval Letter and Labeling,
09-May-2007
This new drug application, NDA 21-829, provides for the use of NEUPRO (rotigotine),
approved for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's
disease. This document contains the approval letter and labeling. - Name of the medicinal
product: NEUPRO - International Nonproprietary Name (INN): rotigotine - Applicant: ...
(Abstract truncated to see more please, go to the document!)
USA - Drug Approval Package (Supplemental Approval): REQUIP (ropinirole
hydrochloride) - Approval Letter and Labeling, 04-May-2005
This supplemental new drug application, NDA 20-658/S013, provides for the use of REQUIP
(ropinirole hydrochloride), approved for the treatment of the signs and symptoms of
idiopathic Parkinson's disease and for the treatment of moderate-to-severe primary Restless
Legs Syndrome (RLS). This document contains the approval letter and labeling. - ...
(Abstract truncated to see more please, go to the document!)
USA - FDA Alert for Healthcare Professionals: Rosiglitazone Maleate (Marketed as
AVANDIA, AVANDAMET and AVANDARYL), 21-MAY-2007
This document contains an FDA alert for health professionals on the possible cardiac risk
related to rosiglitazone maleate, currently assessed by the agency but to date not
confirmed, so that prescribers can take individualized treatment decisions. Recalling that the
Warnings section of AVANDIA's current prescribing information contains information ...
(Abstract truncated to see more please, go to the document!)
USA - FDA Enforcement Report, 16-May-2007
List of recalls for the 3rd week of May 2007.
USA - FDA Enforcement Report, 23-May-2007
List of recalls for the 4th week of May 2007.
USA - FDA Enforcement Report, 30-May-2007
List of recalls for the fifth week of May 2007.
USA - Federal Register: Agency Information Collection Activities; Proposed
Collection; Comment Request; Information Program on Clinical Trials for Serious
or Life-Threatening Diseases: Maintening a Data Bank (Notice), 14-May-2007

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 ... (Abstract truncated to see more please, go to the document!)
USA - Federal Register: Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Guidance for
Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and
Interactions During Development of Fast Track Products Under the Prescription
Drug User Fee Act (Notice), 21-May-2007
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 the
"Guidance for Industry on Continuous Marketing Applications: Pilot — Scientific Feedback
and Interactions ... (Abstract truncated to see more please, go to the document!)
USA - Federal Register: Determination of Regulatory Review for Purposes of
Patent Extension; BEXTRA (Notice), 23-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
BEXTRA and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human drug product.
USA - Federal Register: Determination of Regulatory Review Period for Purpose of
Patent Extension; NOXAFIL (Notice), 21-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
NOXAFIL and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human drug product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; ELAPRASE (Notice), 23-may-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
ELAPRASE and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human biological product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; FOSRENOL (Notice), 22-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
FOSRENOL and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human drug product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; GARDASIL (Notice), 23-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
GARDASIL and is publishing this notice of that determination as required by law. FDA has

made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human biological product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; IRESSA (Notice), 21-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
IRESSA and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a p atent which
claims that human drug product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; MYOZYME (Notice), 25-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
MYOZYME and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human biological product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; ORENCIA (Notice), 23-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
ORENCIA and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human biological product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; PREZISTA (Notice), 25-MAY-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
PREZISTA and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human drug product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; SOMAVERT (Notice), 24-may-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
SOMAVERT and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human drug product.
USA - Federal Register: Draft Guidance for Industry and Review Staff on Labeling
for Human Prescription Drugs - Determining Established Pharmacologic Class for
Use in the Highlights of Prescribing Information; Availability (Notice), 16-May-
2007
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance
for industry and review staff entitled ‘‘Labeling for Human Prescription Drugs—Determining
Established Pharmacologic Class for Use in the Highlights of Prescribing Information.’’
(70103)This guidance is intended to help applicants and the review staff in ... (Abstract
truncated to see more please, go to the document!)

USA - Federal Register: Guidance for Industry on Clinical Trial Endpoints for the
Approval of Cancer Drugs and Biologics; Availability (Notice), 16-May-2007
The Food and Drug Administration (FDA) is announcing the availability of a guidance for
industry entitled ‘‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.’’
(70060) This guidance provides recommendations to applicants on endpoints for cancer
clinical trials submitted to FDA to support effectiveness claims in new drug ... (Abstract
truncated to see more please, go to the document!)
USA - Federal Register: Science Board to the Food and Drug Administration; Notice
of Meeting (Notice), 21-May-2007
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: Science Board to the Food and Drug Administration (Science Board). Date and
Time: The meeting will be held on June 14, 2007, from 8 a.m. to 4 p.m.
USA - Federal Register:Determination of Regulatory Review Periods for Purposes
of Patent Extension; SPRYCEL - New Drug Applications 21-986 and 22-072
(Notice), 25-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
SPRYCEL—new drug applications (NDAs) 21–986 and 22–072 and is publishing this notice of
that determination as required by law. FDA has made the determination because of the
submission of an application to the Director of Patents and Trademarks, Department of
Commerce, ... (Abstract truncated to see more please, go to the document!)
USA - GAO Testimony: Pediatric Drug Research: The Study and Labeling of Drugs
for Pediatric Use under the Best Pharmaceuticals for Children Act, (GAO-07-898T),
22-May-2007
This testimony, provided by Marcia Crosse, Director, Health Care at GAO, is based on GAO
Report GAO-07-557 (70061). GAO assessed (1) the extent to which pediatric drug studies
were being conducted under BPCA for on-patent drugs, (2) the extent to which pediatric
drug studies were being conducted under BPCA for off-patent drugs, and (3) the impact ...
(Abstract truncated to see more please, go to the document!)
USA - Heartland Repack Services LLC, 27-Jun-11-Aug-2006: FDA 483 and
Correspondence
This form FDA 483 was issued at the conclusion of an inspection of drug repacker Heartland
Repack Services in Toledo, Ohio. 23 observations were reported by the FDA investigators. A
warning letter was subsequently sent to the firm (63614).
USA - Hospira, Inc., 23-Sep-11-Oct-2005: EIR
This inspection, conducted in accordance with Compliance Program 7356.002 (Drug
Manufacturing Inspections), was performed as a follow up to information collected in a
previous inspection which indicated marketed drug products did not have completed process
validation. No form FDA 483 was issued at the conclusion of the inspection.
USA - Huntingdon Life Sciences, Inc., 25-Apr-06-May-2005: EIR, FDA 483 and
Correspondence
This inspection was conducted in accordance with Compliance Program 7348.808 (Good
Laboratory Practice (Nonclinical Laboratories)). Inspectional coverage was given to
management & study director responsibilities; personnel qualifications & training; standard
operating procedures; vivarium; test article characterization, preparation, storage and
dosing; ... (Abstract truncated to see more please, go to the document!)

USA - Impact Report: EMEA Meets Performance Goals, But Lags U.S. FDA in Drug
Approvals: EMEA-FDA Goal to Offer Parallel Scientific Advice Likely to Aid
Developers, Feb-2007
Main points in this January/February 2007 report are: - Mean approval times for 71 new
medicinal products approved in the European Union (EU) by the European Medicines Agency
(EMEA) through its centralized procedure and in the United States by the Food and Drug
Administration (FDA) during 2000-05 were nearly identical (15.8 months vs. 15.7 months).
- ... (Abstract truncated to see more please, go to the document!)
USA - Letter: EXJADE (deferasirox) - Novartis, 14-May-2007
This letter from Novartis informs health professionals of the changes brought to the
Warnings and Adverse Events sections of EXJADE (deferasirox)'s prescribing information,
providing information on postmarketing reports of acute renal failure and cytopenias. It
provides detailed safety information and recommendations for monitoring of patients.
USA - Medwatch Safety Alert: AVANDIA (rosiglitazone), 21-May-2007
This document informs health professionals of an ongoing analysis of safety data from
various types of clinical trials related to AVANDIA (rosiglitazone), an antidiabetic agent. As
they show different rates of heart attack or heart-related adverse events, the potential
cardiac risk remains uncertain.
USA - Medwatch Safety Alert: Caffeine Citrated, Powder, Purified, 21-May-2007
This document informs health professionals of the recall by Spectrum of three lots of
Caffeine Citrated, Powder, Purified, a cerebral and respiratory stimulant treating apnea in
premature babies. This product may be subpotent, inducing lower blood levels of caffeine
and a risk of respiratory depression. Health professionals are advised against compounding
with this product.
USA - Medwatch Safety Alert: EXJADE (deferasirox) Tablets for Oral Suspension,
22-May-2007
This document informs health professionals of labeling changes made by Novartis for
EXJADE (deferasirox), indicated for the treatment of chronic iron overload due to blood
transfusion. The Warnings and Adverse Reactions sections have been updated to include
information on postmarketing reports of acute renal failure and cytopenias, including
agranulocytosis, ... (Abstract truncated to see more please, go to the document!)
USA - Medwatch Safety Alert: Integra LifeSciences ENDURA No-React Dural
Substitute, 25-May-2007
The FDA informs of the recall by Integra LifeSciences, classified as class I on May 18, 2007,
of all Shelhigh's ENDURA No-React Dural Substitute products distributed by Integra since
2003. This recall comes after the publication of the April 18, 2007 FDA Preliminary Public
Health Notification (65159) requesting the recall of medical devices manufactured ...
(Abstract truncated to see more please, go to the document!)
USA - Medwatch Safety Alert: Unapproved Guaifenesin Timed-Release Drug
Products, 25-May-2007
The FDA informs about its request that companies marketing unapproved guaifenesin
products in timed-release form, often described as extended-release, long-acting or
sustained-release medicines, should stop manufacturing and marketing these products,
which are used to relieve cough and cold symptoms. The only FDA-approved timed-release
guaifenesin ... (Abstract truncated to see more please, go to the document!)

USA - Presentations: American Association of Bioanalysts Annual Meeting, 17-May-
2007
This document contains two presentations provided by Martha A. Wells, MPH, RAC,
Supervisory Microbiologist at CBER's Division of Human Tissues, for the 2007 American
Association of Bioanalysts Annual Meeting which took place in Orlando, Florida, on May 17-
19, 2007. The following presentations are available in this document: - FDA Update:
Relevant ... (Abstract truncated to see more please, go to the document!)
USA - Presentations: FDA Workshop: Immune Globulins for Primary Immune
Deficiency Diseases: Antibody Specificity, Potency and Testing, 25-26-Apr-2007
This document contains six presentations provided by FDA and CDC members for a
workshop held on April 25-26, 2007 in Bethesda, Maryland. The purpose of the workshop
was to discuss approaches to identify the most relevant antibody specificities in Immune
Globulins for the prevention of infections in patients with primary immune deficiency
diseases, ... (Abstract truncated to see more please, go to the document!)
USA - Press Release: FDA Approves Contraceptive for Continous Use, 22-May-2007
The FDA announces the approval of LYBREL (levonorgestrel/ethinyl estradiol), the first oral
contraceptive agent for continous use. This pill regimen, designed without the usual placebo
or pill-free interval of four to seven days available in other contraceptive methods, induces
unplanned bleeding or spottling instead of a scheduled menstrual period. ... (Abstract
truncated to see more please, go to the document!)
USA - Press Release: FDA Approves Expanded Use for Surgical Sealant, 15-May-
2007
The FDA announces the approval of EVICEL (fibrin sealant), the successor of CROSSEAL, a
plasma product made of fibrinogen concentrate and thrombin, for use in patients
undergoing liver or vascular surgery to control oozing from small blood vessels when other
techniques are not effective or practical. EVICEL is marketed by Omrix Biopharmaceuticals
Ltd.
USA - Press Release: FDA Approves New Drug for Advanced Kidney Cancer, 30-
May-2007
The FDA announces the approval of TORISEL (temsirolimus), an enzyme inhibitor indicated
for the treatment of renal cell carcinoma. The approval of TORISEL follows the approvals in
December 2005 and January 2006 of NEXAVAR (sorafenib) and SUTENT (sunitinib) for this
indication and is based on a clinical trial showing an important progress in overall ...
(Abstract truncated to see more please, go to the document!)
USA - Press Release: FDA Finalizes Guidances for Pandemic and Seasonal
Influenza Vaccines, 31-May-2007
The FDA announces the publication of two final guidances for industry, "Clinical Data
Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines" and "Clinical
Data Needed to Support the Licensure of Pandemic Influenza Vaccines". These guidances,
which draft versions had been published in March 2006 (56471 and 56472) present the ...
(Abstract truncated to see more please, go to the document!)
USA - Press Release: FDA Issues Safety Alert on AVANDIA, 21-May-2007
The FDA informs about the possible heart attack and heart-related death risk associated
with AVANDIA (rosiglitazone), a drug approved in 1999 for treatment of type 2 diabetes,
and states on its current analysis of data from several clinical studies. Available data include
a pooled analysis of 42 clinical trials provided by GlaxoSmithKline, showing ... (Abstract
truncated to see more please, go to the document!)

USA - Press Release: FDA Takes Action to Stop Marketing of Unapproved Timed-
Release Guaifenesin Drug Products, 25-May-2007
The FDA announces, as a part of its initiative related to marketed unapproved drugs, an
action towards around 20 firms marketing unapproved guaifenesin products in timedrelease
dosage forms. These companies should stop manufacturing and marketing these
products within respectively 90 and 180 days or gain FDA approval, necessary for timedrelease
drugs ... (Abstract truncated to see more please, go to the document!)
USA - Product Approval Bulletin: ALTABAX (retapamulin) Ointment, NDA 22-055,
GlaxoSmithKline, 12-Apr-2007
This product approval bulletin summarizes the regulatory history of ALTABAX (retapamulin),
approved by the FDA for the treatment of impetigo.
USA - Product Approval Bulletin: CEPROTIN (protein C concentrate [human])
Injection, BLA 125234, Baxter Healthcare Corporation, 30-Mar-2007
This product approval bulletin summarizes the regulatory history of CEPROTIN (protein C
concentrate [human]), approved by the FDA for patients with Severe Congenital Protein C
Deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.
USA - Product Approval Bulletin: Influenza Virus Vaccine, H5N1 (inactivated
influenza vaccine) Injection, BLA 125244, Sanofi-Pasteur, Inc., 17-Apr-2007
This product approval bulletin summarizes the regulatory history of the Influenza Virus
Vaccine, H5N1 (inactivated influenza vaccine), approved by the FDA for for active
immunization of persons 18 through 64 years of age at increased risk of exposure to the
H5N1 influenza virus subtype contained in the vaccine.
USA - Product Approval Bulletin: SOLIRIS (eculizumab) Infusion, BLA 125166,
Alexion Pharmaceuticals, 16-Mar-2007
This product approval bulletin summarizes the regulatory history of SOLIRIS (eculizumab),
approved by the FDA for treatment of paroxysmal nocturnal hemoglobinuria to reduce
hemolysis.
USA - Questions and Answers About FDA's Enforcement Action Against
Unapproved Timed-Release Guaifenesin Products, 25-May-2007
This document contains questions and answers about the FDA action regarding unapproved
timed-release guaifenesin products, manufactured by around 20 companies and distributed
by about 65 firms. The manufacturing of these products should be stopped by August 27,
2007 and their shipping by November 25, 2007 unless they gain FDA approval, necessary
for timed-release products.
USA - SOPP 8101.1: Scheduling and Conduct of Regulatory Review Meetings with
Sponsors and Applicants, 18-May-2007
The purpose of this document is to describe the procedures involved in the scheduling and
conduct of regulatory meetings between individuals in the Center for Biologics Evaluation
and Research (CBER) and representatives of the regulated industry and/or individual
investigators to address issues relating to product development. It identifies types of ...
(Abstract truncated to see more please, go to the document!)
USA - SOPP 8104: Documentation of Telephone Contacts with Regulated Industry,
08-May-2007
This document describes the procedures that CBER staff should routinely follow regarding
telephone conversations with sponsors/applicants of investigational and marketing

submissions to safeguard the proprietary information in such submissions and to assure that
the administrative record is complete. The same procedures also apply to contacts with ...
(Abstract truncated to see more please, go to the document!)
USA - SOPP 8401: Administrative Processing of Biologics License Application
(BLA), 01-May-2007
This document provides policies and procedures to Center for Biologics Evaluation and
Research (CBER) staff on the administrative processing of the Biologics License Application
(BLA).
USA - Thomas P. Gross, M.D. (Midlands Orthopaedic Group LLC) , 21-Jun-01-Jul-
2005: EIR, FDA 483 and Correspondence
This inspection was conducted in accordance with Compliance Program 7348.811 (Clinical
Investigators). The assignment requested a full data audit to determine the investigator's
compliance with the signed investigator agreement and to FDA regulations. Seven
deficiencies were reported on a form FDA 483 at the conclusion of the investigation. A
warning ... (Abstract truncated to see more please, go to the document!)
USA - Untitled Letter: KV Pharmaceutical Company, 17-May-2007
This untitled letter was sent by FDA's DDMAC (Division of Drug Marketing, Advertising and
Promotion) to KV Pharmaceutical Company to request the removal of violative promotional
material, specifically an e-Pharm/alert e-mail sent by the firm under cover of form FDA
2253 for Clindesse (clindamycin phosphate). The e-Pharm/alert e-mail is false or misleading
... (Abstract truncated to see more please, go to the document!)
USA - Vaccines and Related Biological Products Advisory Committee (Briefing
Information): Safety and Immunogenicity of a Live Vaccinia Virus Smallpox
Vaccine (ACAM2000) Manufactured by Acambis, Inc. 17-May-2007
The Vaccines and Related Biological Products Advisory Committee (63148) voted
unanimously that the safety and efficacy data for ACAM2000 (live vaccinia virus smallpox
vaccine) was sufficient to support the use of the vaccine in high-risk situations. The
committee was also generally positive about the proposed Risk Minimization Action Plan
(RiskMAP). ... (Abstract truncated to see more please, go to the document!)
USA - Warning Letter: Allergan, Inc., 25-May-2007
This warning letter was sent by FDA's DDMAC (Division of Drug Marketing, Advertising and
Communications) to Allergan Inc. (Irvine, California) to request the removal of violative
promotional material, specifically a professional journal advertisement for Acular LS
(ketorolac tromethamine ophthalmic solution) submitted by the firm under cover of form ...
(Abstract truncated to see more please, go to the document!)
USA - Warning Letter: Davol, Inc., Sub C.R. Bard, Inc., 24-Apr-2007
An inspection of CR Bard's subsidiary Davol, Inc. in Cranston, Rhode Island revealed that
the medical devices manufactured by this firm (Composix Kugel Hernia Patches and Salute
Fixation devices) were adulterated as a result of significant deviations from the Quality
System regulations as defined in 21 CFR Part 820. Five deviations are reviewed in this
warning letter.
USA - Warning Letter: Enzon Pharmaceuticals, Inc., 21-May-2007
This warning letter was sent by FDA's DDMAC (Division of Drug Marketing, Advertising and
Communications) to Enzon Pharmaceuticals, Inc. to request the removal of violative
promotional material, specifically a flash card submitted by the firm under cover of form
FDA 2253 for Abelcet (Amphotericin B Lipid Complex Injection). The flash card is misleading

... (Abstract truncated to see more please, go to the document!)
USA - Warning Letter: MedImmune, Inc., 24-May-2007
An inspection of MedImmune U.K. Ltd, Medimmune Inc.'s subsidiary in Liverpool, UK,
revealed significant deviations from current good manufacturing practice in the manufacture
of FluMist bulk monovalent lots used to manufacture Influenza Virus Vaccine Live,
Intranasal. Specific areas of concern include: investigation of bioburden excursions,
production ... (Abstract truncated to see more please, go to the document!)
EPARs
European Union - EMEA EPAR CHMP/65656/04 Rev 4: RAPTIVA (efalizumab),
APR-2007
- Name of the medicinal product: RAPTIVA - International Nonproprietary Name (INN):
efalizumab - Applicant: Serono Europe Limited - Indications: RAPTIVA is indicated for the
treatment of adult patients with moderate to severe chronic plaque psoriasis who have
failed to respond to or who have a contraindication to or are intolerant of other systemic
therapies including cyclosporin, methotrexate ... (Abstract truncated, to see more please, go
to the document)
European Union - EMEA EPAR EMEA/H/C/0113 Rev 22: INVIRASE (saquinavir),
MAY-2007
- Name of the medicinal product: INVIRASE - Marketing Authorisation Holder: Roche
Registration Limited. - International Nonproprietary Name: Saquinavir - Pharmacotherapeutic
group (ATC Code): Antiviral agent (J05A E01) - Therapeutic indication: Invirase
is indicated for the treatment of HIV-1 infected adult patients. Invirase should only be given
in combination with ritonavir and other antiretroviral ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/0128 Rev 18: CRIXIVAN (indinavir),
MAY-2007
- Name of the medicinal product: CRIXIVAN - Marketing Authorisation Holder: Merck Sharp
& Dohme Limited - International Nonproprietary Name: Indinavir - Pharmaco-therapeutic
group - (ATC Code): Antiviral agent - (J05A E02) - Therapeutic indication: CRIXIVAN is
indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1
infected adults, adolescents, and children ... (Abstract truncated, to see more please, go to
the document)
European Union - EMEA EPAR EMEA/H/C/0165 Rev 12: MABTHERA (rituximab),
APR-2007
- Name of the medicinal product: MABTHERA - International Nonproprietary Name:
rituximab - Marketing Authorisation Holder: Roche Registration Limited - Pharmacotherapeutic
group (ATC Code): Antineoplastic Agents, Monoclonal antibodies (L01XC02) -
Therapeutic indication: MabThera is indicated for treatment of patients with stage III-IV
follicular lymphoma who are chromoresistant or are in ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/0363 Rev 8: KINERET (anakinra), MAY-
2007
- Name of the medicinal product: KINERET - International Nonproprietary Name: Anakinra -
Marketing Authorisation Holder: Amgen Europe B.V - Pharmaco-therapeutic group (ATC
code): Immunomodulator - (L04AA14) - Therapeutic indications: Treatment of the
symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that

may occur in patients with overactive bladder syndrome. - ... (Abstract truncated, to see
more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/0369 Rev 8: REPLAGAL (agalsidase alfa),
APR-2007
- Name of the medicinal product: REPLAGAL - Marketing Authorisation Holder: Shire Human
Genetic Therapies AB - International Nonproprietary Name: Agalsidase alfa - Pharmacotherapeutic
group (ATC Code): Other alimentary tract and metabolism products - Enzymes -
A16AB03 agalsidase alfa. - Therapeutic indication: REPLAGAL is indicated for long-term
enzyme replacement therapy in patients with ... (Abstract truncated, to see more please, go
to the document)
European Union - EMEA EPAR EMEA/H/C/0391 Rev 10: LUMIGAN (bimatoprost),
APR-2007
- Name of the medicinal product: LUMIGAN - International Nonproprietary Name:
bimatoprost - Marketing Authorisation Holder: Allergan Pharmaceuticals Ireland - Pharmacotherapeutic
group (ATC Code): Other antiglaucoma preparations (S01EE03) - Therapeutic
indication: Reduction of elevated intraocular pressure in chronic open-angle glaucoma and
ocular hypertension ( as monotherapy or as adjunctive ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/0408 Rev 7: INDUCTOS (dibotermin
alfa), APR-2007
- Name of the medicinal product: INDUCTOS - Marketing Authorisation Holder: Wyeth
Europa Ltd. - International Nonproprietary Name: dibotermin alfa - Pharmaco-therapeutic
group - (ATC Code): Bone morphogenetic protein - (MO5BC01) - Therapeutic indications:
INDUCTOS is indicated for: + the treatment of acute tibia fractures in adults, as an adjunct
to standard care using open fracture reduction ... (Abstract truncated, to see more please,
go to the document)
European Union - EMEA EPAR EMEA/H/C/0474 Rev 6: VENTAVIS (iloprost), APR-
2007
- Name of the medicinal product: VENTAVIS - International Nonproprietary Name (INN):
Iloprost - Marketing Authorisation Holder: Schering AG - Indications: Treatment of patients
with primary pulmonary hypertension, classified as NYHA functional class III, to improve
exercise capacity and symptoms. - Pharmacotherapeutic class (ATC Code): Platelet
aggregation inhibitiors excluding heparin - (B01AC) ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/0511 Rev 8: STALEVO
(levodopa/carbidopa/entacapone (LCE) combination), MAR-2007
- Name of the medicinal product: STALEVO - International Nonproprietary Name: Levodopa
/ Carbidopa / Entacapone (LCE) combination - Applicant: Orion Corporation, Finland. -
Indications: STALEVO is indicated for the treatment of patients with Parkinsons disease and
end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC)
inhibitor treatment. - Pharmacotherapeutic class ... (Abstract truncated, to see more please,
go to the document)
European Union - EMEA EPAR EMEA/H/C/0533 Rev 7: EMTRIVA (emtricitabine),
MAY-2007
- Name of the medicinal product: EMTRIVA - International Nonproprietary Name:
emtricitabine - Marketing Authorisation Holder: Gilead Sciences International Limited,
United Kingdom. - Therapeutic Indications: 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 ... (Abstract truncated, to see more please, go
to the document)
European Union - EMEA EPAR EMEA/H/C/109 Rev 11: RILUTEK (riluzole), APR-
2007
- Name of the Medicinal product: RILUTEK - Marketing Authorisation Holder: Aventis
Pharma S.A. - International Nonproprietary Name: Riluzole - Pharmaco-therapeutic group
(ATC Code): Other Nervous System Drugs - (N07X X02) - Therapeutic indication: RILUTEK
is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic
lateral sclerosis (ALS). - Pharmaceutical Form: ... (Abstract truncated, to see more please,
go to the document)
European Union - EMEA EPAR EMEA/H/C/122 Rev 9: REFLUDAN (lepirudin), APR-
2007
- Name of the medicinal product: REFLUDAN - Marketing Authorisation Holder: Pharmion Ltd
- International Non-proprietary Name: Lepirudin - Pharmaco-therapeutic group (ATC Code):
Other anticoagulants - (B01 AX) - Therapeutic indication: Anticoagulation in adult patients
with heparin-associated thrombocytopenia (HAT) type II and thromboembolic disease
mandating parenteral antithrombotic therapy. - ... (Abstract truncated, to see more please,
go to the document)
European Union - EMEA EPAR EMEA/H/C/125 Rev 8: CYSTAGON (mercaptamine
bitartrate), MAY-2007
- Name of the medicinal product: CYSTAGON - Marketing Authorisation Holder: Orphan
Europe SARL - International Nonproprietary Name: mercaptamine bitartrate - Pharmacotherapeutic
group - (ATC code): Alimentary group: Alimentary tract and metabolism product
- (A16AA04) - Therapeutic indication: CYSTAGON is indicated for the treatment of proven
nephropathic cystinosis. - Pharmaceutical form: Hard ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/132 Rev 8: TASMAR (tolcapone), APR-
2007
- Name of the medicinal product: TASMAR - Marketing Authorisation Holder: Valeant
Pharmaceuticals Ltd - International Nonproprietary Name: tolcapone - Pharmacotherapeutic
group (ATC Code): Anti-Parkinson drug - (NO4 BX01) - Therapeutic indication:
Tasmar is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use
in patients with levodopa-responsive idiopathic Parkinson’s ... (Abstract truncated, to see
more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/150 Rev 7: QUADRAMET (samarium [153
Sm] lexidronam pentasodium), APR-2007
- Name of the medicinal product: QUADRAMET - Marketing Authorisation Holder: CIS bio
international - International Nonproprietary Name: Samarium [153 Sm] lexidronam
pentasodium - Pharmaco-therapeutic group (ATC Code): therapeutic radiopharmaceutical
for pain palliation- (V10BX02) - Therapeutic indication(s): QUADRAMET is indicated for the
relief of bone pain in patients with multiple painful osteoblastic ... (Abstract truncated, to
see more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/175 Rev 15: ISCOVER (clopidogrel),
MAY-2007
- Name of the medicinal product: ISCOVER 75 mg film coated tablets - Marketing
Authorisation Holder: Bristol-Myers Squibb Pharma EEIG - International Nonproprietary

Name: Clopidogrel - Pharmaco-therapeutic group (ATC Code): Platelet aggregation
inhibitors excl. Heparin (BO1 A C04) - Therapeutic indication(s): clopidogrel is indicated for
the prevention of atherothrombotic events in: + patients ... (Abstract truncated, to see
more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/179 Rev 7: ALDARA (imiquimod), MAY-
2007
- Name of the medicinal product: ALDARA - International Nonproprietary Name: imiquimod
- Marketing Authorisation Holder: Laboratoires 3M Santé - Pharmaco-therapeutic group
(ATC Code): Antivirals (D06BB10) - Therapeutic indication: Imiquod cream is indicated for
the topical treatment of external genital and perianal warts (condylomata acuminata) and
small superficial basal cell carcinomas (sBCCs) ... (Abstract truncated, to see more please,
go to the document)
European Union - EMEA EPAR EMEA/H/C/209 Rev 8: MICARDIS (telmisartan),
MAR-2007
- Name of the medicinal product: MICARDIS - Marketing Authorisation Holder: Boehringer
Ingelheim International GmbH - International Nonproprietary Name: Telmisartan -
Pharmaco-therapeutic group (ATC Code): Angiotensin II Antagonists (C09CA07) -
Therapeutic indication(s): Treatment of essential hypertension - Pharmaceutical form: tablet
- Route of administration: Oral use - Packaging: Blister Last ... (Abstract truncated, to see
more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/240 Rev 16: REMICADE (infliximab),
MAY-2007
- Name of the medicinal product: REMICADE - Marketing Authorisation Holder: Centocor
B.V. - International Nonproprietary Name: infliximab - Pharmaco-therapeutic group (ATC
Code): Selective immunosuppressive agents (LO4AA12) - Therapeutic indications: +
Rheumatoid arthritis: Remicade, in combination with methotrexate, is indicated for the
reduction of signs and symptoms as well as the improvement ... (Abstract truncated, to see
more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/273 Rev 11: RAPAMUNE (sirolimus),
APR-2007
- Name of the medicinal product: RAPAMUNE - Marketing Authorisation Holder: Wyeth
Europa Ltd. - International Nonproprietary Name: sirolimus - Pharmaco-therapeutic group
(ATC Code): selective immunosuppressant agents - (LO4A A10), - Therapeutic indication:
Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to
moderate immunological risk receiving a renal ... (Abstract truncated, to see more please,
go to the document)
European Union - EMEA EPAR EMEA/H/C/280 Rev 10: PEGINTRON (peginterferon
alfa-2b), APR-2007
- Name of the medicinal product: PEGINTRON - Marketing Authorisation Holder: SP Europe -
International Nonproprietary Name: Peginterferon alfa-2b - Pharmaco-therapeutic group -
(ATC Code): Immunostimulants, cytokines and immunomodulators, interferons,
peginterferon alfa-2b - (L03A B10) - Therapeutic indications: PegIntron is indicated for the
treatment of adult patients with chronic hepatitis ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/301 Rev 7: NEUROBLOC (botulinum toxin
type B), APR-2007
- Name of the medicinal product: NEUROBLOC - Marketing Authorisation Holder: Elan

Pharma International Ltd. - International Nonproprietary Name: Botulinum toxin type B -
Pharmaco-therapeutic group (ATC Code): Muscle relaxant, peripherally acting agent -
(M03A X01) - Therapeutic indications: NEUROBLOC is indicated for the treatment of cervical
dystonia (torticollis). - Pharmaceutical form: solution ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/406 Rev 9: GLIVEC (imatinib mesilate),
MAY-2007
- Name of the medicinal product: GLIVEC - Marketing Authorisation Holder: Novartis
Europharm Ltd. - International Nonproprietary Name: imatinib mesilate - Therapeutic
Indication: + Glivec is indicated for the treatment of adult patients with newly diagnosed
Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for
whom bone marrow transplantation is not considered as ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/407 Rev 5: OPATANOL (olopatadine
(Hydrochloride), MAR-2007
- Name of the medicinal product: OPATANOL - Marketing Authorisation Holder: Alcon
Laboratories (UK) Ltd. - International Nonproprietary Name: Olopatadine - Pharmacotherapeutic
group (ATC Code): Ophthalmologicals; Decongestants and antiallergics; Other
antiallergics (S01GX09) - Therapeutic indication: OPATANOL is indicated for the treatment
of occular signs and symptoms of seasonal allergic conjunctivitis. - ... (Abstract truncated,
to see more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/413 Rev 6: MICARDISPLUS (telmisartan
and hydrochlorothiazide), MAR-2007
- Name of the medicinal product: MICARDISPLUS - International Nonproprietary Name:
telmisartan and hydrochlorothiazide - Applicant: Boehringer Ingelheim International GmbH -
Pharmaco-therapeutic group (ATC Code): Antihypertensive agents, Angiotensin II
antagonists, diuretics (ATC Code: C09DA) - Therapeutic indications: Treatment of essential
hypertension. MICARDISPLUS fixed dose combination (40mg ... (Abstract truncated, to see
more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/415 Rev 8: KINZALKOMB (telmisartan
and hydrochlorothiazide), APR-2007
- Name of the medicinal product: KINZALKOMB - International Nonproprietary Name:
Telmisartan and hydrochlorothiazide - Applicant: Bayer Healthcare AG - Pharmacotherapeutic
group (ATC Code): Antihypertensive agents, Angiotensin II antagonists,
diuretics (ATC Code: C09D A) - Therapeutic indications: Treatment of essential
hypertension. Kinzalkomb fixed dose combination (40 mg telmisartan/12.5 ... (Abstract
truncated, to see more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/480 Rev 5: XAGRID (anagrelide), APR-
2007
- Name of the medicinal product: XAGRID - International Nonproprietary Name (INN):
anagrelide - Applicant: Shire Pharmaceutical Contracts Limited - Indications: Xagrid is
indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia
patients who are intolerant to their current therapy or whose elevated platelet counts are
not reduced to an acceptable level by ... (Abstract truncated, to see more please, go to the
document)
European Union - EMEA EPAR EMEA/H/C/481 Rev 6: HUMIRA (adalimumab), MAY-
2007

- Name of the medicinal product: HUMIRA - International Nonproprietary Name (INN):
Adalimumab - Applicant: Abbott Laboratories Ltd - Indications: Humira, in combination with
methotrexate, is indicated for: - the treatment of moderate to severe active rheumatoid
arthritis in adult patients when the response to disease-modifying antirheumatic drugs
including methotrexate has been inadequate ... (Abstract truncated, to see more please, go
to the document)
European Union - EMEA EPAR EMEA/H/C/494 Rev 7: REYATAZ (atazanavir), MAY-
2007
- Name of the medicinal product: REYATAZ - International Nonproprietary Name (INN):
atazanavir - Applicant: Bristol-Myers Squibb Pharma EEIG - Indications: REYATAZ is
indicated for the treatment of HIV-1 infected, antiretroviral treatment experienced adults, in
combination with other antiretroviral medicinal products. - Pharmaco-therapeutic group
(ATC Code): Protease inhibitors - (JO5A E). - ... (Abstract truncated, to see more please, go
to the document)
European Union - EMEA EPAR EMEA/H/C/512 Rev 3: CHOLESTAGEL (colesevelam),
MAY-2007
- Name of the medicinal product: CHOLESTAGEL - International Nonproprietary Name
(INN): colesevelam - Applicant: Genzyme Europe B.V. - Indications: + Cholestagel coadministered
with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive
therapy to diet to provide an additive reduction in LDL-cholesterol (LDL-C) levels in patients
with primary hypercholesterolaemia who are not ... (Abstract truncated, to see more please,
go to the document)
European Union - EMEA EPAR EMEA/H/C/528 Rev 5: LEVEMIR (insulin detemir),
APR-2007
- Name of the medicinal product: LEVEMIR - International Nonproprietary Name (INN):
insulin detemir - Marketing Authorisation Holder: Novo Nordisk A/S - Indications: LEVEMIR
is indicated for the treatment of diabetes mellitus. - Pharmacotherapeutic class (ATC Code):
Antidiabetic agent. Insulin and analogues, long-acting - A10AE 05. - Pharmaceutical form:
Solution for injection - Pakaging: ... (Abstract truncated, to see more please, go to the
document)
European Union - EMEA EPAR EMEA/H/C/545 Rev 6: YENTREVE (duloxetine),
MAR-2007
- Name of the medicinal product: YENTREVE - International Nonproprietary Name (INN):
duloxetine - Marketing Authorisation Holder: Eli Lilly Netherlands B.V. - Indications:
YENTREVE is indicated for women for the treatment of moderate to severe stress urinary
incontinence (SUI) - Pharmacotherapeutic class (ATC Code): Other urologicals - (N06 AX21)
- Pharmaceutical form: Hard gastro-resistant ... (Abstract truncated, to see more please, go
to the document)
European Union - EMEA EPAR EMEA/H/C/554 Rev 5: EMSELEX (darifenacin), MAY-
2007
- Name of the medicinal product: EMSELEX - International Nonproprietary Name:
darifenacin - Applicant: Novartis Europharm Limited - Indications: EMSELEX is indicated for
the symptomatic treatment of urge incontinence and/or increased urinary frequency and
urgency as may occur in patients with overactive bladder syndrome. - Pharmacotherapeutic
class (ATC Code): Urological antispasmodic medicinal ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/555 Rev 2: ORFADIN (nitisinone), APR-

2007
- Name of the medicinal product: ORFADIN - International Nonproprietary Name: nitisinone
- Marketing Authorisation Holder: SWEDISH ORPHAN INTERNATIONAL - Pharmacotherapeutic
group (ATC Code): Other alimentary and metabolism products (A16A X04) -
Therapeutic indication: Treatment of patients with confirmed diagnosis of hereditary
tyrosinemia type 1 (HT-1) in combination with dietary restriction ... (Abstract truncated, to
see more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/557 Rev 6: APIDRA (insulin glulisine),
MAY-2007
- Name of the medicinal product: APIDRA - International Nonproprietary Name: AVENTIS
PHARMA DEUTSCHLAND GmbH - Marketing Authorisation Holder: Insulin glulisine -
Pharmaco-therapeutic group (ATC Code): Antidiabetic Agent, fast-acting human insulin
analogue (A10AB06) - Therapeutic indication: Treatment of adult patients with diabetes
mellitus. - Pharmaceutical form: solution for injection - Route ... (Abstract truncated, to see
more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/558 Rev 5: ERBITUX (cetuximab), MAY-
2007
- Name of the medicinal product: ERBITUX - International Nonproprietary Name (INN):
cetuximab - Applicant: Merck KGaA - Indications: ERBITUX in combination with irinotecan is
indicated for the treatment of patients with EGFR-expressing metastatic colorectal cancer
after failure of irinotecan-including cytotoxic therapy. - Pharmacotherapeutic class (ATC
Code): - (L01XC06) - Pharmaceutical form: ... (Abstract truncated, to see more please, go
to the document)
European Union - EMEA EPAR EMEA/H/C/560 Rev 2: PROTELOS (strontium
ranelate), MAR-2007
- Name of the medicinal product: PROTELOS - International Nonproprietary Name (INN):
strontium ranelate - Applicant: Les Laboratoires Servier, France - Indications: PROTELOS is
indicated for the treatment of adult postmenopausal osteoporsis to reduce the risk of
vertebral and hip fractures. - Pharmacotherapeutic class (ATC Code): Drugs for the
treatment of bone diseases - Other drugs affecting ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/561 Rev 3: OSSEOR (strontium
ranelate), MAR-2007
- Name of the medicinal product: OSSEOR - International Nonproprietary Name (INN):
strontium ranelate - Applicant: Les Laboratoires Servier, France - Indications: OSSEOR is
indicated for the treatment of adult postmenopausal osteoporsis to reduce the risk of
vertebral and hip fractures. - Pharmacotherapeutic class (ATC Code): Drugs for the
treatment of bone diseases - Other drugs affecting bone ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/582 Rev 3: AVASTIN (bevacizumab),
MAY-2007
- Name of the medicinal product: AVASTIN - International Nonproprietary Name:
bevacizumab - Applicant: Roche Registration Limited - Indications: AVASTIN (bevacizumab)
in combination with intravenous 5-fluorouracil/folinic acid or intravenous 5fluorouracil/folinic
acid/irinotecan is indicated for first-line treatment of patients with
metastatic carcinoma of the colon or rectum. - Pharmacotherapeutic ... (Abstract truncated,
to see more please, go to the document)

European Union - EMEA EPAR EMEA/H/C/594 Rev 8: TRUVADA
(emtricitabine/tenofovir disoproxil fumarate), MAY-2007
- Name of the medicinal product: TRUVADA - International Nonproprietary Name (INN):
Emtricitabine and tenofovir disoproxil (as fumarate) - Applicant: Gilead Sciences
International Limited - Indications: 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 ... (Abstract truncated, to see
more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/597 Rev 2: PROCORALAN (ivabradine),
MAR-2007
- Name of the Medicinal Product: PROCORALAN - International Nonproprietary Name (INN):
ivabradine - Marketing Authorisation Holder: Les Laboratoires Servier - Pharmacotherapeutic
group (ATC Code): Other cardiac preparations - (C01EB17) - Therapeutic
indications: Symptomatic treatment of chronic stable angina pectoris in patients with
normal sinus rhythm, who have a contra-indication or intolerance ... (Abstract truncated, to
see more please, go to the document)
European Union - EMEA EPAR EMEA/H/C/601: VASOVIST Rev 1 (gadofosveset),
APR-2007
- Name of the medicinal product: VASOVIST - International Nonproprietary Name (INN):
gadofosveset - Marketing Authorisation Holder: Schering AG - Pharmaco-therapeutic group -
(ATC Code): Paramagnetic contrast media - (V08CA) - Therapeutic Indications: For
contrast-enhanced magnetic resonance angiography for visualization of abdominal or limb
vessels in patients with suspected or known vascular ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/603 Rev 1: TYSABRI (natalizumab),
MAR-2007
- Name of the medicinal product: TYSABRI - International Nonproprietary Name:
natalizumab - Marketing Authorisation Holder: Elan Pharma International Ltd. - Therapeutic
Indication: TYSABRI is indicated as single disease modifying therapy in highly active
relapsing remitting multiple sclerosis for the following patient groups: + Patients with high
disease activity despite treatment with a ... (Abstract truncated, to see more please, go to
the document)
European Union - EMEA EPAR EMEA/H/C/610 Rev 2: NOXAFIL (posaconazole),
MAR-2007
- Name of the Medicinal Product: NOXAFIL - International Nonproprietary Name (INN):
posaconazole - Marketing Authorisation Holder: Schering-Plough Europe - Pharmacotherapeutic
group (ATC Code): Antimycotics for Systemic use - Triazole Derivatives - (J02A
C - pending) - Therapeutic indications: POSACONAZOLE SP is indicated for use in the
treatment of the following invasive fungal infections in ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/611 Rev 2: POSACONAZOLE SP
(posaconazole), MAR-2007
- Name of the Medicinal Product: POSACONAZOLE SP - International Nonproprietary Name
(INN): posaconazole - Marketing Authorisation Holder: Schering-Plough Europe - Pharmacotherapeutic
group (ATC Code): Antimycotics for Systemic use - Triazole Derivatives - (J02A
C - pending) - Therapeutic indications: POSACONAZOLE SP is indicated for use in the
treatment of the following invasive fungal infections ... (Abstract truncated, to see more
please, go to the document)

European Union - EMEA EPAR EMEA/H/C/618 Rev 3: TARCEVA (erlotinib), APR-
2007
- Name of the Medicinal Product: TARCEVA - International Nonproprietary Name (INN):
erlotinib - Marketing Authorisation holder: Roche Registration Limited - Pharmacotherapeutic
group (ATC Code): Antineoplastic agent- (L01XX34) - Therapeutic indications:
TARCEVA is indicated for the treament of patients with locally advanced or metastatic nonsmall
cell lung cancer after failure of at least one ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/623 Rev 1: BARACLUDE (entecavir),
MAY-2007
- Name of the medicinal product: BARACLUDE - International Nonproprietary Name:
entecavir - Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG - Therapeutic
Indication: BARACLUDE is indicated for the treatment of chronic hepatitis B virus (HBV)
infection in adults with compensated liver disease and evidence of active viral replication,
persistently elevated serum alanine aminotransferase ... (Abstract truncated, to see more
please, go to the document)
European Union - EMEA EPAR EMEA/H/C/638 Rev 6: REVATIO (sildenafil), APR-
2007
- Name of the Medicinal Product: REVATIO - International Nonproprietary Name (INN):
sildenafil - Marketing Authorisation Holder: Pfizer Limited - Pharmaco-therapeutic group -
(ATC Code): Drugs used in erectile dysfunction - (G04B E03) - Therapeutic indications:
Treatment of patients with pulmonary arterial hypertension classified as WHO functional
class III, to improve exercise capacity. Efficacy ... (Abstract truncated, to see more please,
go to the document)
European Union - EMEA EPAR EMEA/H/C/644 Rev 1: TYGACIL (tigecycline), APR-
2007
- Name of the medicinal product: TYGACIL - International Nonproprietary Name: tigecycline
- Marketing Authorisation Holder: Wyeth Europa Ltd - Therapeutic Indication: TYGACIL is
indicated for the treatment of: + complicated skin and soft tissue infections + complicated
intra-abdominal infections - Pharmaco-therapeutic group (ATC Code): (Not yet assigned) -
Pharmaceutical form: Powder ... (Abstract truncated, to see more please, go to the
document)
European Union - EMEA EPAR EMEA/H/C/679 Rev 2: THELIN (sitaxentan sodium),
APR-2007
- Name of the medicinal product: THELIN - International Nonproprietary Name: sitaxentan
sodium - Marketing Authorisation Holder: Encysive (UK) Limited - Therapeutic Indication:
THELIN is indicated in the treatment of patients with pulmonary arterial hypertension
classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown
in primary pulmonary hypertension associated ... (Abstract truncated, to see more please,
go to the document)
MUSTERTEXTS
Germany - Mustertext: Acetylcysteine - Oral Forms - Package Leaflet - 03-May-
2007 Official example of the Package Leaflet (Gebrauchsinformation) for Acetylcysteine -
oral forms - prepared by BfArM. This is the 16th revision.
Germany - Mustertext: Acetylcysteine - Oral Forms - Technical Information Leaflet

(SPC) - 03-May-2007 Official example of the Technical Information Leaflet
(Fachinformation) for Acetylcysteine - oral forms - prepared by BfArM. This is the 14th
revision.
Germany - Mustertext: Naproxen (Pharmacy Only) - Oral Forms - Technical
Information Leaflet (SPC) - 07-Mar-2007 Official example for the Technical Information
Leaflet (Fachinformation) of Naproxen - tablets / film coated tablets - prepared by BfArM.
This is the 3rd revision correction a.
Germany - Mustertext: Paracetamol - Oral and Rectal Forms - Package Leaflet -
27-Mar-2007 Official example of the package leaflet (Gebrauchsinformation) of
paracetamol, oral and rectal forms, prepared by BfArM.
Germany - Mustertext: Paracetamol - Oral and Rectal Forms - Technical
Information Leaflet (SPC) - 27-Mar-2007 Official Example of the Technical Information
Leaflet (Fachinformation) of paracetamol, oral and rectal forms, prepared by BfArM.
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