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Europe Daily Bulletin No. 9176

21 April 2006
Contents Publication in full By article 21 / 42
GENERAL NEWS / (eu) eu/medicines
First biosimilar drug on EU market

Brussels, 20/04/2006 (Agence Europe) - On 20 April the European Commission granted the first marketing authorisation for a biosimilar product since the adoption of the revised EU pharmaceutical legislation in 2004. The medicament, Omnitrope, is intended for the treatment of growth disturbance and growth hormone deficiency in children and adults. It had been evaluated and given a positive scientific opinion by the European Medicines Agency in January 2006. Omnitrope has been shown by studies...

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