HYCAMTIN - HYCAMTIN - CT 4386 - English version

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Description

Introduction HYCAMTIN 4 mg, Powder for concentrate for solution for infusion Pack of 1 glass vial: 560 545-2 Posted on Feb 15 2010 Active substance (DCI) topotecan ATC Code L01XX17 Laboratory / Manufacturer GLAXOSMITHKLINE HYCAMTIN 4 mg, Powder for concentrate for solution for infusion Pack of 1 glass vial: 560 545-2 Posted on Feb 15 2010

Sujets

• Médecine

Informations

• Publié par: haute-autorite-sante-traitement-medicamenteux
• Publié le: 09 mai 2007
• Nombre de lectures: 16
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

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    The legally binding text is the original French version     TRANSPARENCY COMMITTEE

OPINION   9 May 2007     HYCAMTIN 4 mg, Powder for concentrate for solution for infusion Pack of 1 glass vial: 560 545-2   Applicant: GLAXOSMITHKLINE   topotecan   List I Prescription restricted to oncologists or haematologists, or doctors competent in oncology. Medicinal product requiring specific monitoring during treatment.     Date of Marketing Authorisation (centralised procedure): November 12, 1996 – Variations of January 13, 2006 and November 22, 2006           Reason for request: Inclusion on the list of medicines approved for hospital in the new indication: “topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IV-B disease”.                           Health Technology Assessment Division

 

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