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Amgen
EU Commission Approves Updated Prescribing Information for Aranesp(R)
March 21st, 2008
Amgen (NASDAQ: AMGN) announced that the European Commission reached its final decision to amend the prescribing information for Aranesp(R) (darbepoetin alfa) based on the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) in January 2008. The CHMP granted positive opinions for all centrally-authorized Erythropoiesis Stimulating Agents (ESAs) in the European Union (EU), each of which will receive European Commission Decisions. The European Commission's decision announced is consistent with that described in Amgen's press release on Sept. 28, 2007 and the European Medicines Agency's (EMEA) announcement on Oct. 23, 2007. A summary of...
Source: Health Business Week (2008-03-21)
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