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Human medicine European public assessment report (EPAR): Oxbryta
Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
Date of authorisation: 14/02/2022,,
, Revision: 1, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Ngenla
somatrogon, Growth and Development
Date of authorisation: 14/02/2022,,
, Revision: 2, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Minjuvi
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,,
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, Revision: 3, Authorised, Last updated: 11/04/2022
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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,,
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, Revision: 4, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,,
, Revision: 9, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Jemperli
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,,
, Revision: 2, Authorised, Last updated: 06/04/2022
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Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,,
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, Revision: 4, Authorised, Last updated: 05/04/2022
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Human medicine European public assessment report (EPAR): Farydak
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,, Revision: 11, Authorised, Last updated: 05/04/2022
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Human medicine European public assessment report (EPAR): Palynziq
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,,
, Revision: 4, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,,
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, Revision: 1, Authorised, Last updated: 04/04/2022
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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): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,,
, Revision: 10, Authorised, Last updated: 28/03/2022
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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): Gavreto
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,,
, Revision: 1, Authorised, Last updated: 24/03/2022
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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): 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