HERCEPTIN - HERCEPTIN - CT 5302 - English version

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2008

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2008

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19 mars 2008

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Introduction HERCEPTIN 150 mg, powder for concentrate for solution for infusion Pack of 1 15 ml vial (CIP: 562 103-7) Posted on Mar 24 2010 Active substance (DCI) trastuzumab ATC Code L01XC03 Laboratory / Manufacturer ROCHE HERCEPTIN 150 mg, powder for concentrate for solution for infusion Pack of 1 15 ml vial (CIP: 562 103-7) Posted on Mar 24 2010

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Publié par

haute-autorite-sante-cancers

Publié le

19 mars 2008

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En savoir +

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The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION

19 March 2008 HERCEPTIN 150 mg, powder for concentrate for solution for infusion Pack of 1 15 ml vial (CIP: 562 103-7) Applicant : ROCHE Laboratory trastuzumab List I Medicinal product available only on hospital prescription. To be prescribed only by oncology, haematology and cancer specialists. Medicinal product requiring specific monitoring during treatment. First administration must take place in a hospital environment. Date of the marketing authorisation (centralised): 28 August 2000 Marketing authorisation amendments: 10 June 2004 22 October 2004 28 Apirl 2005 - 22 May 2006 (extension to early breast cancer) 24 April 2007 (extension of indication to be evaluated). Reason for request: Inclusion on the list of medicines approved for use by hospitals in the extension of indication “Herceptin is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab. Health Technology Assessment Division

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