AVASTIN - AVASTIN - CT 5390 - English version

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2008

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2008

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Introduction AVASTIN 25 mg/ml Pack of 1 vial containing 4 ml (CIP: 566 200-7) Pack of 1 vial containing 16 ml (CIP: 566 201-3) Posted on May 21 2009 Active substance (DCI) bevacizumab ATC Code L01XC07 Laboratory / Manufacturer ROCHE AVASTIN 25 mg/ml Pack of 1 vial containing 4 ml (CIP: 566 200-7) Pack of 1 vial containing 16 ml (CIP: 566 201-3) Posted on May 21 2009
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14 mai 2008

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Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique

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English

 
 
 
 
The legally binding text is the original French version
TRANSPARENCY COMMITTEE
OPINION
 
 14 May 2008     AVASTIN 25 mg/ml Pack of 1 vial containing 4 ml (CIP: 566 200-7) Pack of 1 vial containing 16 ml (CIP: 566 201-3)  Applicant: ROCHE  bevacizumab  List I Medicinal product reserved for hospital use. To be prescribed only by specialists or oncologists or cancer specialists  ATC Code: L01XC07  Dates of MA and variations: Centralised MA: 12 January 2005: metastatic colorectal cancer MA variations: 27 March 2007: extension of indication: metastatic breast cancer 21 August 2007: extension of indication: to be assessed  Reason for request: Inclusion on the list of medicines approved for use by hospitals in the extension of indication “Avastin, in addition to platinum-based chemotherapy, is indicated for first line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology”.           Health Technology, Economic and Public Health Assessment Division
  
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