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Swedish Orphan Biovitrum AB Receives EMA Approval to Manufacture Kineret Drug Substance with Partner Boehringer Ingelheim-DJ


Wednesday, 23 Jan 2013 02:31am EST 

Dow Jones reported that Swedish Orphan Biovitrum AB announced receipt of approval from the European Medicines Agency (EMA) for the manufacture of drug substance for Kineret (anakinra) at Boehringer Ingelheim's microbial site in Vienna, Austria. The approval allows for distribution of Kineret to EMA territory countries, and comes as the result of an application filed with the EMA in October of 2012. A similar application has been filed with the United States FDA (Food and Drug Administration) and authorities in other countries where Kineret is approved. 

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