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