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news.Orexo's licensing partner for Rapinylin Europe, ProStrakan Group has announced that Rapinyl has received Swedish marketing authorization.
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It is anticipated that the product branded as ‘Abstral’ will be launched in Sweden in the third quarter of 2008 through Orexo’s joint venture with ProStrakan, the international specialty pharmaceutical company, which operates in the Nordic countries.
Sweden is the reference member state (RMS) for the wider EU regulatory filing of Rapinyl. The Swedish Medical Products Agency has decided to issue a marketing authorization for Sweden alone, based on its assessment report made as a RMS for the EU regulatory procedure.
Rapinyl is a fast-dissolving tablet for sublingual administration of fentanyl intended for the treatment of breakthrough cancer pain, for which ProStrakan Group has in-licensed exclusive rights in Europe from Orexo.