miércoles, 27 de julio 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
Alprolix®
(eftrenacog alfa)
Biogen Idec Ltd
Haemophilia B
12/05/2016
Coagadex®
(human coagulation factor X)
Bio Products Laboratory Limited
Hereditary factor X deficiency
16/03/2016
Darzalex®
(daratumumab)
Janssen-Cilag International N.V.
Multiple myeloma
20/05/2016
Galafold®
(migalastat)
Amicus Therapeutics UK Ltd
Fabry disease
16/05/2016
Idelvion®
(albutrepenonacog alfa)
CSL Behring GmbH
Haemophilia B
11/05/2016
Strimvelis®
(autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence)
GlaxoSmithKline Trading Services Limited
Severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID)
26/05/2016
Uptravi®
(selexipag)*
Actelion Registration Ltd
Pulmonary arterial hypertension
12/05/2016
Wakix®
(pitolisant)
Bioprojet Pharma
Narcolepsy
31/03/2016

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

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