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Image header Agence Europe
Europe Daily Bulletin No. 9120
Contents Publication in full By article 27 / 32
GENERAL NEWS / (eu) eu/medicines

30/01/2006 (Agence Europe) - At its meeting on 23-26 January, the European Medicines Agency's Committee for Medicinal Products for Human Use, for the first time as in new European pharmaceutical legislation, adopted a positive opinion for a similar biological medicinal product in the framework of the centralised placing on the market authorisation procedure. The product, Omnitrope, is manufactured by Sandoz GmbH and contains somatropin, a recombinant-DNA growth hormone. It is intended for the treatment of growth disturbance and growth hormone deficiency in children and adults. The committee considered that Omnatrope had, in accordance with European Union requirements, been shown to be comparable in terms of quality, safety and efficacy to a reference medicinal product already authorised by the EU, Genotropin, made by the American Pfizer laboratory. Various generics of this medicine are already on the market.

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