2016 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

Lartruvo®
(olaratumab)

Eli Lilly Nederland B.V.

Advanced soft tissue sarcoma

09/11/2016

Ninlaro®
(ixazomib citrate)

Takeda Pharma A/S

Multiple myeloma

21/11/2016

Ocaliva®
(obeticholic acid)

Intercept Pharma Ltd

Primary biliary cholangitis

12/12/2016

Onyvide®
(irinotecan hydrochloride trihydrate)

Baxalta Innovations GmbH

Metastatic adenocarcinoma of the pancreas

14/10/2016

SomaKit TOC®
(edotreotide)

Advanced Accelerator Applications

Gastroenteropancreatic neuroendocrine tumours

8/12/2016

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

Venclyxto®
(venetoclax)

AbbVie Ltd

Chronic lymphocytic leukemia

05/12/2016

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)