quinta-feira, outubro 18, 2007

Atripla aprovado pela EMEA

EMEA 18.10.07

London, 18 October 2007
Doc. Ref. EMEA/479200/2007
Meeting highlights from the Committee for Medicinal Products for Human Use,
15-18 October 2007

Positive opinions
The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted 7 positive opinions, including 2 for biosimilar medicinal products and 1 for
a generic medicinal product, recommending the granting of a marketing authorisation for the following medicinal products:
Atripla [efavirenz/emtricitabine/tenofovir disoproxil (as fumarate)], from Bristol-Myers Squibb Gilead Sciences and Merck Sharp & Dohme Limited, for treatment of human immunodeficiency virus-1 (HIV-1) infection in adults. EMEA review began on 25 October 2006 with an active review time of 202 days.

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