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.

Learn 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 SpA	Adjunctive treatment in adults who have received a haematopoietic stem cell transplant from a partially matched donor	18/08/2016