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Meda AB (MDABF.PK): European Approval for Breakyl


10/20/2010 9:48:03 AM

STOCKHOLM--(BUSINESS WIRE)--Regulatory News: Meda (STO:MEDAA) announced today that Breakyl (fentanyl) has received approval in Europe via the Decentralized Procedure with Germany acting as Reference Member State. Breakyl (also known as Onsolis or BEMA Fentanyl) is indicated for the management of breakthrough pain in opioid tolerant adult patients with cancer. National registration processes will now follow in each of the individual countries. Throughout next year, it is expected that major countries in Europe will issue marketing authorizations for Breakyl. Thereafter, price and reimbursement will be negotiated on a national level.

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