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)
|
MolMed SpA |
Adjunctive treatment in adults who have received a haematopoietic stem cell transplant from a partially matched donor |
18/08/2016 |
*Препарат удален из Журнала орфанных препаратов по просьбе владельца регистрационного удостоверения на момент рассмотрения заявки на прохождение регистрации
Marketing authorisations since 2000
Page created: 06/03/2017
Page last updated: 08/03/2017