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HYCAMTIN - HYCAMTIN - CT 4386 - English version

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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

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Published 09 May 2007
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Language English
  
 
  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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