miércoles, 10 de mayo de 2017

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

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 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
Cystadrops®
(mercaptamine)
Orphan Europe S.A.R.L.
Cystinosis
19/01/2017
Ledaga®
(chlormethine)
Actelion Registration Ltd.
Mycosis fungoides-type cutaneous
T-cell lymphoma

03/03/2017
(parathyroid hormone)
Shire Pharmaceuticals Ireland Ltd
Hypoparathyroidism

24/04/2017












*Removed from the Community register of orphan medicinal products upon request of the MAH at the time of marketing authorisation

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