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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: 7, Authorised, Last updated: 16/08/2019
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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
telmisartan, hydrochlorothiazide,
Date of authorisation: 13/03/2013,
, Revision: 9, Authorised, Last updated: 18/01/2019
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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): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Authorised, Last updated: 15/07/2019
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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: 7, Authorised, Last updated: 30/10/2019
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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: 4, Authorised, Last updated: 21/05/2019
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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: 1, Authorised, Last updated: 25/04/2019
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 8, Authorised, Last updated: 30/07/2019
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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: 8, Authorised, Last updated: 29/07/2019
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 6, Authorised, Last updated: 27/05/2019
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 6, Authorised, Last updated: 19/07/2019
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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,, Authorised, Last updated: 26/11/2019
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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: 6, Authorised, Last updated: 15/04/2019
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban acetate, Premature Birth
Date of authorisation: 31/07/2013,, Revision: 6, Authorised, Last updated: 09/10/2019
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, , Revision: 22, Authorised, Last updated: 22/01/2020
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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): 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 (updated)
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
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 6, Authorised, Last updated: 10/04/2019