CUBICIN - CUBICIN - CT 5417 - English version
11 pages
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CUBICIN - CUBICIN - CT 5417 - English version

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11 pages
English
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Description

Introduction CUBICIN 350 mg (daptomycin), powder for solution for infusion Box containing 1 bottle (CIP: 567 219-3) CUBICIN 500 mg (daptomycin), powder for solution for infusion Box containing 1 bottle (CIP: 567 220-1) Posted on Nov 10 2009 Active substance (DCI) daptomycin ATC Code J01XX09 Laboratory / Manufacturer NOVARTIS PHARMA S.A.S CUBICIN 350 mg (daptomycin), powder for solution for infusion Box containing 1 bottle (CIP: 567 219-3) CUBICIN 500 mg (daptomycin), powder for solution for infusion Box containing 1 bottle (CIP: 567 220-1) Posted on Nov 10 2009

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Publié par
Publié le 28 mai 2008
Nombre de lectures 23
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  28 May 2008   CUBICIN 350 mg (daptomycin), powder for solution for infusion Box containing 1 bottle (CIP: 567 219-3)  CUBICIN 500 mg (daptomycin), powder for solution for infusion  Box containing 1 bottle (CIP: 567 220-1)   Applicant: NOVARTIS PHARMA S.A.S  daptomycin   List I Medicinal product for hospital use only   Marketing Authorisation (MA) date: 19 January 2006, amending the authorisation of 31 August 2007 European MA, centralised procedure   Reason for request: Inclusion on the list of medicines approved for use by hospitals in the extension of indication: - Right-sided infective endocarditis (RIE) due toStaphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. - Staphylococcus aureus (SAB) when associated with RIE or with bacteraemia Complicated skin and soft-tissue infections (cSSTI).           Medical, Economic and Public Health Assessment Division
 
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