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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
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