2017 marketing authorisations

 

Medicinal Product

Marketing Authorisation Holder

Therapeutic Indication

Date of Marketing Authorisation

Bavencio®
(avelumab)

Merck Serono Europe Limited Merkel cell carcinoma 18/09/2017
Besponsa®
(inotuzumab ozogamicin)
Pfizer Limited Precursor Cell Lymphoblastic Leukemia-Lymphoma 29/06/2017
Brineura®
(cerliponase alfa)
Biomarin International Limited Neuronal ceroid lipofuscinosis type 2 30/05/2017

Cystadrops®
(mercaptamine)

Orphan Europe S.A.R.L.

Cystinosis

19/01/2017

Dinutuximab beta Apeiron®
(dinutuximab beta)

Apeiron Biologics AG

Neuroblastoma

08/05/2017

Ledaga®
(chlormethine)

Actelion Registration Ltd.

Mycosis fungoides-type cutaneous

T-cell lymphoma

03/03/2017

Natpar®

(parathyroid hormone)

Shire Pharmaceuticals Ireland Ltd

Hypoparathyroidism

24/04/2017

Oxervate®
(cenegermin [recombinant human nerve growth factor])
Dompe farmaceutici s.p.a. Neurotrophic keratitis 06/07/2017

Rydapt®
(midostaurin)

 

Novartis Europharm Ltd Acute myeloid leukemia, systemic mastocytosis 18/09/2017

Spinraza®
(nusinersen)

Biogen Idec Ltd

Spinal muscular atrophy

30/05/2017

 

Xermelo®
(telotristat etiprate)

 

Ipsen Pharma Carcinoid syndrome 18/09/2017

 

Zejula®
(niraparib)

Tesaro UK limited Fallopian tube neoplasms, ovarian neoplasms, peritoneal neoplasms 16/11/2017

 

Marketing authorisations since 2000

Page created: 06/03/2017
Page last updated: 19/02/2018
 
 
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