EU Panel Recommends Positive Opinion For Clopidogrel Teva Pharma
23 Juillet 2010 - 12:48PM
Dow Jones News
The Committee for Medicinal Products for Human Use, or CHMP,
said Friday it has adopted a positive opinion for recommending the
granting of marketing authorisations for Clopidogrel Teva Pharma
B.V. (clopidogrel, as hydrobromide), from Teva Pharma B.V., for the
prevention of atherothrombotic events.
MAIN FACTS:
-Clopidogrel Teva Pharma B.V. is a generic of Plavix.
-Positive opinions adopted for:
* Clopidogrel HCS and Clopidogrel Teva Generics B.V.
(clopidogrel, as hydrochloride), from Teva Pharma B.V. and from HCS
bvba, for the prevention of atherothrombotic events. Clopidogrel
HCS and Clopidogrel Teva Generics B.V. are generics of Plavix.
* Myclausen (mycophenolate mofetil), from Herbert J. Passauer
GmbH & Co. KG, for the prophylaxis of acute transplant
rejection in combination with ciclosporin and corticosteroids.
Myclausen is a generic of Cellcept.
-Positive opinions for extensions of indications adopted:
* Arixtra (fondaparinux sodium), from Glaxo Group Ltd, to
include treatment of acute symptomatic spontaneous superficial vein
thrombosis of the lower limbs without concomitant deep vein
thrombosis.
* M-M-RVAXPRO (measles, mumps and rubella vaccine live), from
Sanofi Pasteur MSD, SNC, to include vaccination of healthy children
from 9 months of age under special circumstances, in accordance
with official recommendations or when early protection is
considered necessary.
* Viread (tenofovir disoproxil), from Gilead Sciences
International Ltd, to include treatment of chronic hepatitis B in
adults with decompensated liver disease.
-New paediatric indication for Xalatan
-CHMP finalized a review of the oral vaccine Rotarix (rotavirus
vaccine, live) from GlaxoSmithKline Biologicals S.A., following the
detection of porcine circovirus 1 (PCV1) DNA in the vaccine;
Committee concluded that the vaccine continues to have a positive
benefit-risk balance and that the presence of a very small amount
of viral particles does not present a risk to public health.
-The review of the rotavirus vaccine, Rotateq, from Sanofi
Pasteur MSD, SNC, following the detection of porcine virus in this
vaccine is still ongoing and will be considered in September; CHMP
is awaiting further information from the manufacturer on the root
cause of the findings and on measures to manufacture the vaccine
free of porcine virus. While this review is still ongoing, the
Committee confirmed its previous position that there is no need to
restrict the use of Rotateq.
-By Ian Walker, Dow Jones Newswires; 44-20-7842-9296;
ian.walker@dowjones.com