158 results
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Human medicine European public assessment report (EPAR): Symkevi (updated)
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,
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, Revision: 7, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)
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 (updated)
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): Wakix (updated)
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 9, Authorised, Last updated: 21/01/2021
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, 
, Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Holoclar (updated)
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 7, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Foclivia (updated)
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,
, Revision: 10, Authorised, Last updated: 13/01/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, , Revision: 1, Authorised, Last updated: 12/01/2021
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Human medicine European public assessment report (EPAR): Daurismo (updated)
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,, , Revision: 1, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 8, Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Luxturna (updated)
voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa
Date of authorisation: 22/11/2018,, , Revision: 3, Authorised, Last updated: 05/01/2021
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Human medicine European public assessment report (EPAR): Alofisel (updated)
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 6, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, , Revision: 4, Authorised, Last updated: 22/12/2020
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Human medicine European public assessment report (EPAR): Mylotarg
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, , Revision: 7, Authorised, Last updated: 21/12/2020
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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,, , , Revision: 28, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene)
Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013,, , Revision: 17, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Isturisa
Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020,, , Revision: 3, Authorised, Last updated: 17/12/2020
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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,, , , Revision: 14, Authorised, Last updated: 17/12/2020
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 7, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Ledaga
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 5, Authorised, Last updated: 16/12/2020
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Human medicine European public assessment report (EPAR): Polivy
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, , , Revision: 2, Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013,, , Revision: 18, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 5, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , , Revision: 6, Authorised, Last updated: 10/12/2020