Osteoporosis

Pharma company submits application to market osteoporosis medicine in Europe

Published in Women's Health Weekly, April 28th, 2005

Nycomed and its U.S. collaborator NPS Pharmaceuticals Inc. (NPSP) have received confirmation from the European Medicines Agency (EMEA) that assessment of the market authorization application (MAA) for Preotact in Europe has now begun.

The application will now be assessed under the centralized approval procedure, which, following an approval, grants the applicant the right to market the product in all EU markets.

"We believe that the data submitted demonstrate the safety and efficacy of Preotact and support the approval of the product for treatment of osteoporosis in postmenopausal women. With a positive assessment from EMEA, Preotact could be ready...

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Source: Women's Health Weekly (2005-04-28)

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