lunes, 21 de noviembre de 2016

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
ORPHAN MEDICINES
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
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
Onyvide®
(irinotecan hydrochloride trihydrate)
Baxalta Innovations GmbH
Metastatic adenocarcinoma of the pancreas
14/10/2016
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
Zalmoxis®
(allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor and the herpes simplex I virus thymidine kinase)
MolMed SpAAdjunctive treatment in adults who have received a haematopoietic stem cell transplant from a partially matched donor18/08/2016
































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

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