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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
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): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,
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, Revision: 25, Authorised, Last updated: 08/06/2020
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Human medicine European public assessment report (EPAR): Adynovi
rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018,, Revision: 3, Authorised, Last updated: 23/08/2019
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Human medicine European public assessment report (EPAR): Afstyla
lonoctocog alfa, Hemophilia A
Date of authorisation: 04/01/2017,, Revision: 6, Authorised, Last updated: 11/11/2019
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Human medicine European public assessment report (EPAR): Aimovig
erenumab, Migraine Disorders
Date of authorisation: 26/07/2018,, Revision: 4, Authorised, Last updated: 04/05/2020
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Human medicine European public assessment report (EPAR): Ajovy
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 2, Authorised, Last updated: 27/01/2020
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Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 8, Authorised, Last updated: 19/06/2020
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Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 4, Authorised, Last updated: 12/02/2020
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Human medicine European public assessment report (EPAR): Alpheon
recombinant human interferon alfa-2a, Hepatitis C, Chronic
Date of refusal: 05/09/2006,, Refused, Last updated: 28/06/2006
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Human medicine European public assessment report (EPAR): Alpivab
Peramivir, Influenza, Human
Date of authorisation: 13/04/2018,, Revision: 1, Authorised, Last updated: 12/06/2019
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Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,, , Revision: 4, Authorised, Last updated: 10/04/2019
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Human medicine European public assessment report (EPAR): Alunbrig (updated)
brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018,, Revision: 2, Authorised, Last updated: 11/06/2020
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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 (updated)
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): Anoro Ellipta (previously Anoro)
umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 13, Authorised, Last updated: 17/10/2019
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 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