JEVTANA - JEVTANA - CT 12292 - Version anglaise

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Description

Présentation JEVTANA 60 mg, solution à diluer et solvant pour solution pour perfusion Boite de 1 flacon de solution et 1 flacon de solvant - Code CIP : 5798497 Mis en ligne le 21 mai 2013 Substance active (DCI) cabazitaxel Code ATC L01CD04 Laboratoire / fabricant SANOFI-AVENTIS FRANCE JEVTANA 60 mg, solution à diluer et solvant pour solution pour perfusion Boite de 1 flacon de solution et 1 flacon de solvant - Code CIP : 5798497 Mis en ligne le 21 mai 2013

Sujets

• Cancer
• Médecine

Informations

• Publié par: haute-autorite-sante-cancers
• Publié le: 17 octobre 2012
• Nombre de lectures: 12
• 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   17 October 2012     The draft Opinion adopted by the Transparency Committee on 3 October 2012 was examined at a hearing on 17 October 2012     JEVTANA 60 mg, concentrate and solvent for solution for infusion Box with 1 vial of concentrate and 1 vial of solvent (CIP code: 579 849-7)   Applicant: SANOFI-AVENTIS FRANCE   Cabazitaxel    List I Reserved for hospital use Prescription restricted to oncology or haematology specialists or doctors with cancer training. Medicine requiring special monitoring during treatment.   Approved for use by hospitals and various public services (Official Gazette of 27 March 2012).       Date of Marketing Authorisation (centralised procedure): 17 March 2011       Reason for request: Re-assessment of the Improvement in Actual Benefit following submission of new data, on the initiative of the applicant, in accordance with Article L. 163-12 of the French Social Security Code.                             Medical, Economic and Public Health Assessment Division

 

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