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Medicine
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi (updated)
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,
, Revision: 8, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Grepid (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 27/07/2009,, Revision: 21, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Zonisamide Mylan (updated)
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, 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,
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, Revision: 7, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Krka (updated)
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 15, Authorised, Last updated: 13/01/2021
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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): Daptomycin Hospira (updated)
daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 22/03/2017,, Revision: 9, 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): Telmisartan Actavis (updated)
telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 10, Authorised, Last updated: 05/01/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 15, Authorised, Last updated: 04/01/2021
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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): Mylotarg (updated)
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 (updated)
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) (updated)
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): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, , Revision: 26, Authorised, Last updated: 16/12/2020
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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): Clopidogrel Mylan
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 16, 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): Marixino (previously Maruxa)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 28/04/2013,, Revision: 7, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Pramipexole Accord
pramipexole dihydrochloride monohydrate, Parkinson Disease, Restless Legs Syndrome
Date of authorisation: 29/09/2011,, Revision: 10, Authorised, Last updated: 11/12/2020