Medicinal Product
|
Marketing Authorisation Holder
|
Therapeutic Indication
|
Date of Marketing Authorisation
|
Isturisa®
(osilodrostat) |
Novartis Europharm Limited |
Cushing Syndrome |
09/01/2020 |
Polivy®
(polatuzumab vedotin) |
Roche Registration GmbH |
Diffuse large B-cell lymphoma (DLBCL) |
16/01/2020 |
Givlaari®
(givosiran) |
Alnylam Netherlands B.V. |
Acute hepatic
porphyria |
02/03/2020 |
Trepulmix®
(treprostinil) |
SciPharm Sàrl |
Chronic
thromboembolic
pulmonary
hypertension
(CTEPH) |
03/04/2020 |
Zolgensma®
(onasemnogene
abeparvovec) |
AveXis EU Limited |
Spinal muscular
atrophy (SMA) |
18/05/2020 |
Reblozyl®
(luspatercept) |
Celgene Europe B.V. |
Beta thalassaemia & Myelodysplastic syndromes |
25/06/2020 |
Daurismo®
(glasdegib) |
Pfizer Europe MA EEIG |
Newly-diagnosed acute myeloid leukaemia (AML) |
26/06/2020 |
Pretomanid FGK
(pretomanid) |
FGK Representative Service GmbH |
Adults with drug-resistant tuberculosis |
31/07/2020 |
Hepcludex
(bulevirtide) |
MYR GmbH |
Chronic (long-term) hepatitis delta virus (HDV) infection in adults |
31/07/2020 |
Idefirix
(imlifidase) |
Hansa Biopharma AB |
Prevent the body from rejecting a newly transplanted kidney |
25/08/2020 |
Kaftrio
(ivacaftor / tezacaftor / elexacaftor) |
Vertex Pharmaceuticals (Ireland) Limited |
Cystic fibrosis |
21/08/2020 |
Blenrep
(belantamab mafodotin) |
GlaxoSmithKline (Ireland) Limited |
Multiple Myeloma |
25/08/2020 |
Ayvakyt
(avapritinib) |
Blueprint Medicines (Netherlands) B.V. |
Gastrointestinal stromal tumour (GIST) |
24/09/2020 |
Arikayce liposomal
(amikacin sulfate) |
Insmed Netherlands B.V. |
Adults with a lung
infection caused by
Mycobacterium avium
complex (MAC) |
27/10/2020 |
Adakveo
(crizanlizumab) |
Novartis Europharm Limited |
Anemia, Sickle Cell |
28/10/2020 |
Obiltoxaximab SFL
(obiltoxaximab) |
SFL Pharmaceuticals Deutschland GmbH |
Anthrax |
18/11/2020 |
Oxlumo
(lumasiran) |
Alnylam Netherlands B.V. |
Hyperoxaluria, Primary |
19/11/2020 |
Libmeldy
(autologous CD34+
cells encoding ARSA
gene) |
Orchard Therapeutics
(Netherlands) BV |
Metachromatic
leukodystrophy (MLD) |
17/12/2020 |
Fintepla®
(fenfluramine) |
Zogenix ROI Limited |
Seizures associated
with Dravet syndrome |
18/12/2020 |