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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
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, Revision: 3, Authorised, Last updated: 01/04/2022
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,,
, Revision: 18, Authorised, Last updated: 01/04/2022
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Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis
Date of authorisation: 18/09/2017,,
, Revision: 7, Authorised, Last updated: 01/04/2022
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Human medicine European public assessment report (EPAR): Adcetris
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,,
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, Revision: 32, Authorised, Last updated: 31/03/2022
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Human medicine European public assessment report (EPAR): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,,
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, Revision: 13, Authorised, Last updated: 31/03/2022
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Human medicine European public assessment report (EPAR): Imcivree
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,,
, Revision: 2, Authorised, Last updated: 31/03/2022
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,,
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, Revision: 20, Authorised, Last updated: 25/03/2022
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 6, Authorised, Last updated: 24/03/2022
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Human medicine European public assessment report (EPAR): Opsumit
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 19, Authorised, Last updated: 23/03/2022
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Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,,
, Revision: 15, Authorised, Last updated: 22/03/2022
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,,
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, Revision: 10, Authorised, Last updated: 18/03/2022
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,,
, Revision: 7, Authorised, Last updated: 18/03/2022
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Human medicine European public assessment report (EPAR): Lonapegsomatropin Ascendis Pharma
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,,
, Authorised, Last updated: 16/03/2022
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Human medicine European public assessment report (EPAR): Besponsa
inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,, Revision: 9, Authorised, Last updated: 16/03/2022
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Human medicine European public assessment report (EPAR): Ravicti
glycerol phenylbutyrate, Urea Cycle Disorders, Inborn
Date of authorisation: 26/11/2015,, Revision: 14, Authorised, Last updated: 09/03/2022
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Human medicine European public assessment report (EPAR): Symkevi
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,,
, Revision: 9, Authorised, Last updated: 09/03/2022
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Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,,
, Revision: 8, Authorised, Last updated: 04/03/2022
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Human medicine European public assessment report (EPAR): Pemazyre
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,,
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, Revision: 2, Authorised, Last updated: 02/03/2022
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Human medicine European public assessment report (EPAR): Revestive
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,,
, Revision: 18, Authorised, Last updated: 01/03/2022
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Human medicine European public assessment report (EPAR): Oxlumo
Lumasiran sodium, Hyperoxaluria, Primary
Date of authorisation: 19/11/2020,,
, Revision: 2, Authorised, Last updated: 25/02/2022
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Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,,
, Revision: 21, Authorised, Last updated: 24/02/2022
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Human medicine European public assessment report (EPAR): Voxzogo
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,,
, Revision: 1, Authorised, Last updated: 24/02/2022
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,,
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, Revision: 5, Authorised, Last updated: 23/02/2022
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Human medicine European public assessment report (EPAR): Epidyolex
Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 10, Authorised, Last updated: 22/02/2022
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Human medicine European public assessment report (EPAR): Aspaveli
Pegcetacoplan, Hemoglobinuria, Paroxysmal
Date of authorisation: 13/12/2021,,
, Revision: 1, Authorised, Last updated: 21/02/2022