miércoles, 20 de mayo de 2020

List of the latest marketing authorisations and orphan medicinal products designations | www.eurordis.org

List of the latest marketing authorisations and orphan medicinal products designations | www.eurordis.org

Eurordis, Rare Diseases Europe

List of the latest marketing authorisations and orphan medicinal products designations

Detailed information on European orphan medicinal products designation applications is available on the EMA 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
Isturisa®
(osilodrostat)
Novartis Europharm LimitedCushing Syndrome09/01/2020
Polivy®
(polatuzumab vedotin)
Roche Registration GmbHDiffuse large B-cell lymphoma (DLBCL)16/01/2020
Givlaari®
(givosiran)
Alnylam Netherlands B.V.Acute hepatic
porphyria
02/03/2020

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