miércoles, 25 de mayo de 2016

Latest marketing authorisations and orphan drug designations

Latest marketing authorisations and orphan drug designations

Eurordis, Rare Diseases Europe

The Voice of Rare Disease
Patients in Europe


List of the latest marketing authorisations and orphan medicinal products designations

Detailed information on European orphan medicinal products designation applications is available on theEMA website. A full list of designated and authorised orphan medicinal products in Europe available at:ec.europa.eu.

Orphan drug regulatory processLearn more about the Orphan designation process in Europe

Recent marketing authorisations

Medicinal Product
Marketing Authorisation Holder
Therapeutic Indication
Date of Marketing Authorisation
(human coagulation factor X)
Bio Products Laboratory Limited
Hereditary factor X deficiency
Bioprojet Pharma

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