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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 10, Authorised, Last updated: 14/12/2020
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Human medicine European public assessment report (EPAR): Abseamed
epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 11, Authorised, Last updated: 24/08/2020
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Human medicine European public assessment report (EPAR): Actelsar HCT
telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 12, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
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, Authorised, Last updated: 24/11/2020
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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,,
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, Revision: 28, Authorised, Last updated: 18/12/2020
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Human medicine European public assessment report (EPAR): Adempas
riociguat, Hypertension, Pulmonary
Date of authorisation: 27/03/2014,, Revision: 10, Authorised, Last updated: 29/04/2019
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 10/10/2009,, Revision: 10, Authorised, Last updated: 06/11/2019
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Human medicine European public assessment report (EPAR): Alofisel
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): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,,
, Revision: 5, Authorised, Last updated: 04/11/2020
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 1, Authorised, Last updated: 20/03/2020
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Human medicine European public assessment report (EPAR): Amgevita
adalimumab, Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,,
, Revision: 8, Authorised, Last updated: 12/03/2020
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 3, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan (updated)
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 6, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Amsparity
adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, Hidradenitis Suppurativa
Date of authorisation: 13/02/2020,,
, Revision: 1, Authorised, Last updated: 01/12/2020
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 2, Authorised, Last updated: 08/06/2020
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Human medicine European public assessment report (EPAR): Apixaban Accord
Apixaban, Venous Thromboembolism, Stroke, Arthroplasty
Date of authorisation: 23/07/2020,, Authorised, Last updated: 06/08/2020
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 11, Authorised, Last updated: 21/10/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 10, Authorised, Last updated: 24/06/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/07/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 7, Authorised, Last updated: 17/06/2020
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Human medicine European public assessment report (EPAR): Arsenic trioxide Accord
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 14/11/2019,, Revision: 2, Authorised, Last updated: 16/09/2020
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Human medicine European public assessment report (EPAR): Arsenic trioxide medac
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Authorised, Last updated: 01/10/2020
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,, Authorised, Last updated: 17/04/2020