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453 results
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,
, Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,
, , Revision: 11, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, , Revision: 9, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, 
, , Revision: 11, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , 
, Revision: 20, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 1, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 8, Authorised, Last updated: 01/02/2021
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Human medicine European public assessment report (EPAR): Rydapt (updated)
Midostaurin, Leukemia, Myeloid, Acute, Mastocytosis
Date of authorisation: 18/09/2017,, , Revision: 4, Authorised, Last updated: 01/02/2021
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Human medicine European public assessment report (EPAR): Gazyvaro (updated)
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,, , Revision: 11, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Blenrep (updated)
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 1, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Defitelio (updated)
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , 
, Revision: 13, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Zynteglo (updated)
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , , , Revision: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Strimvelis (updated)
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,, , Revision: 5, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 18, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 4, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,, , , Revision: 6, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, , Revision: 13, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Lutathera (updated)
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, , Revision: 4, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , , Revision: 15, Authorised, Last updated: 26/01/2021
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Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 4, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 8, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Blincyto
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 11, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 27, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Symkevi
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, , Revision: 7, Authorised, Last updated: 22/01/2021