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news.Amgen has reported that the European Commission reached its final decision to amend the prescribing information for Aranesp based on the positive opinion from the European Committee for Medicinal Products for Human Use or CHMP in January 2008.
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The Commission amended the information regarding SmPCs, dosage adjustments, Posology and method of administration, and therapeutic indication for Aranesp. The CHMP granted positive opinions for all centrally-authorized erythropoiesis stimulating agents (ESAs) in the EU, each of which will receive European Commission decisions.