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Afssaps

A) Information for pharmaceutical companies which already ...

Afssaps - French Health Products Safety Agency - June 2009 1 Electronic exchanges of individual case safety reports (ICSRs) with Afssaps Information for pharmaceutical companies June 2009.

Q/R Information_for women_ with PIP breastimplants

REPUBLIQUE FRANÇAISE 143/147, bd Anatole France - F-93285 Saint-Denis cedex - tél. +33 (0)1 55 87 30 00 - www.afssaps..fr 1 / 3 Information for women with PIP breast implants 1 What kind of breast implants are involved with the decision? 2 What is the problem with these implants? 3 How can I ...

AFSSAPS - EGA INFO DAY

EUROPEAN GENERIC MEDICINES ASSOCIATION Rue d'Arlon 50, B-1000 Brussels, Belgium T: +32-(0)2-736 8411 F: +32-(0)2-736 7438 E: info@egagenerics.com www.egagenerics.com VAT: BE 0449 332 209 EUROPEAN GENERIC MEDICINES ASSOCIATION Organised in conjunction with www.gpaconferences.com AFSSAPS - EGA ...

Recommendations to clinical trial sponsors concerning the ...

AFSSaPS Page 1/13 Juillet 2003 MEDICINAL PRODUCTS AND BIOLOGICS EVALUATION DEPARTMENT Special status - Information and Therapeutics Recommendations - Clinical trials Division Clinical Trial Unit - Huriet Law Recommendations to clinical trial sponsors concerning the clinical trial authorisation ...

Temporary Authorisations for Use (ATU)

Role of the Afssaps and the pharmacovigilance unit The Afssaps studies the information sent to it by the company or organisation distributing the medicinal product and the Regional Pharmacovigilance Centres and takes all necessary measures to ensure correct use of the medicinal product.

20091218 fr345346 noliterax pl

2 PACKAGE LEAFLET: INFORMATION FOR THE USER NOLITERAX 10mg/2.5mg film-coated tablets perindopril arginine/indapamide Read all of this leaflet carefully before you start taking this medicine.

PUBLIC ASSESSMENT REPORT Scientific Discussion

Diamicron 60 mg, modified release Tablet/ PAR Page 1 of 7

PRACTICAL DOCUMENTS

Examples of substantial and non-substantial amendments to be notified to AFSSAPS Page 3 of 22 PRESENTATION OF THE DOCUMENT SCOPE N.B. This document only addresses the requirements of AFSSAPS (the French competent authority), and not those of the French Ethics Committees (CPP).

Afssaps response to the Commission's consultation detailed ...

G:\GRP_SPI\essais cliniques\BRX\2009-2010\vigilance\public consultation\CT3_public consultation july 2010_cmtCBB_revPHB.doc 15 July 2010 Afssaps response to the Commission's consultation detailed guidance on the collection, verification and presentation of adverse reactions reports arising from ...

French Health Products Safety Agency (Afssaps) selects SALTO ...

French Health Products Safety Agency (Afssaps) selects SALTO SYSTEMS. The French Health Products Safety Agency (Afssaps) was created by the law of 1 July 1998, passed to strengthen