TYGACIL - TYGACIL - CT 11250 - English version

Has

Description

Introduction TYGACIL 50 mg, powder for solution for infusion B/10 glass vials of 50 mg (CIP code: 567 032-0) Posted on Nov 30 2011 Active substance (DCI) tigecycline ATC Code J01AA12 Laboratory / Manufacturer PFIZER TYGACIL 50 mg, powder for solution for infusion B/10 glass vials of 50 mg (CIP code: 567 032-0) Posted on Nov 30 2011

Sujets

• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 30 novembre 2011
• Nombre de lectures: 13
• 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   30 November 2011     TYGACIL 50 mg, powder for solution for infusion B/10 glass vials of 50 mg (CIP code: 567 032-0)       Applicant: PFIZER   Tigecycline    ATC code: J01 AA12 to a subgroup of the tetracyclines: the belonging  (antibiotic glycylcyclines)     List I Medicinal product reserved for hospital use   Date of Marketing Authorisation: 24 April 2006, correction of MA on 6 May 2011 (modification to the therapeutic indication)   European MA by the centralised procedure     Reason for request: Re-assessment of the actual benefit in accordance with article R.163-21 of the Social Security Code. This re-assessment follows a pharmacovigilance alert relating to an increased mortality observed in the course of clinical studies carried out both in indications validated and not validated by the Marketing Authorisation (MA).                                   Medical, Economic and Public Health Assessment Division  

 

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