APTIVUS - APTIVUS - CT 6249 - English version

Has

Description

Introduction APTIVUS 250 mg, soft capsule Bottle of 120 capsules (CIP: 369 252-4) Posted on Mar 01 2011 Active substance (DCI) tipranavir ATC Code J05AE09 Laboratory / Manufacturer BOEHRINGER INGELHEIM APTIVUS 250 mg, soft capsule Bottle of 120 capsules (CIP: 369 252-4) Posted on Mar 01 2011

Sujets

• Pédiatrie
• Infection sexuellement transmissible
• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 10 mars 2010
• Nombre de lectures: 14
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

 

     

  The legally binding text is the original French version  

TRANSPARENCY COMMITTEE     OPINION   10 March 2010     APTIVUS 250 mg, soft capsule Bottle of 120 capsules (CIP: 369 252-4)       Applicant: BOEHRINGER INGELHEIM   Tipranavir J05AE09   List I Medicine for initial hospital prescription. Unrestricted renewal.   Medicinal product for prescription only by certain specialists: physicians who are experienced in the treatment of HIV-1 infection.       Date of Marketing Authorisation: (centralised procedure)   25/10/2005: Marketing Authorisation granted subject to special conditions given the lack of long-term data for the two phase III efficacy and tolerance studies. 22/04/2008: Previous conditions lifted. Latest corrections to the Marketing Authorisation taken into account: 23 June 2009     Reason for request: Re-examination following the submission of new data and the amendment of the wording of the therapeutic indication.                                   Medical, Economic, and Public Health Assessment Division  

 

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