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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: 8, Authorised, Last updated: 17/03/2020
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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: 10, Authorised, Last updated: 13/06/2019
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)
telmisartan, hydrochlorothiazide,
Date of authorisation: 13/03/2013,
, Revision: 10, Authorised, Last updated: 09/07/2020
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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): Amlodipine / Valsartan Mylan
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 5, Authorised, Last updated: 01/04/2020
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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,, , Authorised, Last updated: 14/02/2020
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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): Aripiprazole Accord
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 9, Authorised, Last updated: 24/03/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
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: 7, Authorised, Last updated: 14/05/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva (updated)
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 (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 14/11/2019,, Revision: 1, Authorised, Last updated: 08/07/2020
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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
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Human medicine European public assessment report (EPAR): Atazanavir Krka
atazanavir sulfate, HIV Infections
Date of authorisation: 25/03/2019,, Authorised, Last updated: 15/05/2019
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Human medicine European public assessment report (EPAR): Atazanavir Mylan
atazanavir sulfate, HIV Infections
Date of authorisation: 22/08/2016,, Revision: 8, Authorised, Last updated: 22/04/2020
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban acetate, Premature Birth
Date of authorisation: 31/07/2013,, Revision: 7, Authorised, Last updated: 29/04/2020
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Authorised, Last updated: 21/02/2020
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Authorised, Last updated: 01/04/2020
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Authorised, Last updated: 06/04/2020
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Human medicine European public assessment report (EPAR): Bemfola
follitropin alfa, Anovulation
Date of authorisation: 26/03/2014,, Revision: 8, Authorised, Last updated: 10/01/2019
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Human medicine European public assessment report (EPAR): Benepali
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, , Revision: 11, Authorised, Last updated: 30/01/2020
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Human medicine European public assessment report (EPAR): Binocrit
epoetin alfa, Anemia, Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 20, Authorised, Last updated: 31/10/2019
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Human medicine European public assessment report (EPAR): Blitzima
rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, , Revision: 8, Authorised, Last updated: 13/01/2020