2018 marketing authorisations

 

Medicinal Product

Marketing Authorisation Holder

Therapeutic Indication

Date of Marketing Authorisation

Alofisel®
(darvadstrocel)
Tigenix, S.A.U. Complex anal fistulas in adults with Crohn’s disease 23/03/2018
Amglidia®
(glibenclamide)
Ammtrek Neonatal diabetes 24/05/2018
Cablivic®
(caplacizumab)
Ablynx NV Acquired thrombotic thrombocytopenic purpura (aTTP) 31/10/2018
Crysvita®
(burosumab)
Kyowa Kirin Limited  X-linked hypophosphataemia  19/02/2018

Jorveza®
(budesonide)

Dr. Falk Pharma GmbH Eosinophilic oesophagitis 08/01/2018
Kymriah®
(tisagenlecleucel)
Novartis Europharm Limited B-cell acute lymphoblastic leukaemia (ALL), in children and young adults up to 25 years and diffuse large B-cell lymphoma (DLBCL) in adults 22/08/2018

Lamzede®
(velmanase alfa)

Chiesi Farmaceutici S.p.A. Alpha-mannosidosis 23/03/2018
Luxturna®
(voretigene neparvovec)
Spark Therapeutics Ireland Ltd Adults and children with loss of vision due to inherited retinal dystrophy 22/11/2018
Mepsevii®
(vestronidase alfametreleptin)
Ultragenyx Germany GmbH Mucopolysaccharidosis type VII (MPS VII, also known as Sly syndrome) 23/08/2018
Myalepta®
(metreleptin)
Aegerion Pharmaceuticals B.V. Lipodystrophy 30/07/2018

Mylotarg®
(gemtuzumab ozogamicin)

Pfizer Limited Acute myeloid leukemia 19/04/2018
Namuscla®
(mexiletine hcl)
Lupin Europe GmbH Non-dystrophic myotonic disorders 18/12/2018
Onpattro®
(patisiran)
Alnylam Netherlands B.V. Hereditary transthyretin-mediated amyloidosis (hATTR) 26/08/2018
Premyvis®
(letermovir)

Merck Sharp & Dohme Limited

Cytomegalovirus infection prevention following haematopoietic stem cell transplant 08/01/2018

Rubraca®
(rucaparib)

Clovis Oncology UK Limited High-grade cancers of the ovary, fallopian tubes and peritoneum

24/05/2018

 

Symkevi®
(tezacaftor/ivacaftor)
Vertex Pharmaceuticals (Europe) Ltd. Cystic fibrosis in patients aged 12 years and above 31/10/2018
Tegsedi®
(inotersen sodium)
Ionis USA Ltd Hereditary transthyretin amyloidosis (hATTR) 06/07/2018
Verkazia®
(ciclosporin)
Santen Oy Keratoconjunctivitis (VKC) in children and adolescents from 4 to 18 years of age. 06/07/2018

Vyxeos®
(daunoribicin/cytarabine)

Jazz Pharmaceuticals Ireland Limited Adults with newly diagnosed acute myeloid leukaemia 22/08/2018

Yescarta®
(axicabtagene ciloleucel)

Kite Pharma EU B.V.  Diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) 23/08/2018

 

Marketing authorisations since 2000

Page created: 06/03/2017
Page last updated: 04/07/2019
 
 
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