NeLM news service
CHMP recommends approval of a number of generic medicines

Source: EMEA

Date published: 05/10/2009 15:49

Summary
by: Nicola Pocock

The CHMP of the EMEA Committee has adopted nine positive opinions by consensus for the following generic medicines, for which a reference medicine is already authorised in the EU. The medicines concerned are:

 

• Irbesartan Hydrochlorothiazide Teva (irbesartan hydrochlorothiazide), from Teva Pharma B.V., a generic of CoAprovel®, indicated for the treatment of hypertension;

• Lamivudine Teva Pharma B.V. (lamivudine), from Teva Pharma B.V., a generic of Epivir®, indicated as part of antiretroviral combination therapy for the treatment of human immunodeficiency virus (HIV)-infected adults and children;

• Olanzapine Glenmark Europe, Olanzapine Glenmark (olanzapine), from Glenmark Generics (Europe) Ltd, and Olazax Desperzi and Olazax (olanzapine), from Glenmark Phamaceuticals s.r.o., all generics of Zyprexa®, indicated for the treatment of schizophrenia and moderate to severe manic episodes;

• Sildenafil Actavis (sildenafil citrate), from Actavis Group PTC and Sildenafil Teva (sildenafil citrate) from Teva Pharma B. V., both generics of Viagra®, intended to treat erectile dysfunction;

• Nevirapine Teva (nevirapine), from Teva Pharma B.V., a generic of Viramune®, indicated for treatment of HIV-1-infected adults, adolescents, and children of any age.

 

Further information will be included in the European Public Assessment Reports (EPARs) once the European Commission has granted final approval.

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