TEPADINA - TEPADINA - CT 11752 - English version

Has

Description

Introduction TEPADINA , powder for concentrate for solution for infusion B/1 15 mg bottle (CIP code: 578 903-8) B/1 100 mg bottle (CIP code: 578 904-4) Posted on Dec 14 2011 Active substance (DCI) thiotepa ATC Code L01AC01 Laboratory / Manufacturer RIEMSER Arzneimittel AG TEPADINA , powder for concentrate for solution for infusion B/1 15 mg bottle (CIP code: 578 903-8) B/1 100 mg bottle (CIP code: 578 904-4) Posted on Dec 14 2011

Sujets

• Cancer
• Médecine

Informations

• Publié par: haute-autorite-sante-cancers
• Publié le: 14 décembre 2011
• Nombre de lectures: 15
• 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   14 December 2011       TEPADINA , powder for concentrate for solution for infusion B/1 15 mg bottle (CIP code: 578 903-8)   B/1 100 mg bottle (CIP code: 578 904-4)       Applicant: RIEMSER Arzneimittel AG   thiotepa ATC code (2011): L01AC01 (alkylating agent)     Orphan medicinal product (29 January 2007)   List I   Medicinal product reserved for hospital use.   Prescription restricted to oncology or haematology specialists or doctors with cancer training. Medicine requiring special monitoring during treatment.   Date of Marketing Authorisation (centralised European procedure): 15 March 2010       Reason for request: Inclusion on the list of medicines approved for hospital use.       Because of a disruption to the supply of the only thiotepa-based product on the list of medicines approved for hospital use in France, the Directorate-General for Health (DGS) requested a review by the transparency Committee at the earliest possible opportunity.                     Medical, Economic and Public Health Assessment Division

 

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