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European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Orphan designations Remove Orphan designations filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Summaries of opinion (17) Apply Summaries of opinion filter Withdrawn applications (67) Apply Withdrawn applications filter

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter Paediatric investigation plans Remove Paediatric investigation plans filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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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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Veterinary medicine European public assessment report (EPAR): Acticam

meloxicam, Dogs, Cats
Date of authorisation: 09/12/2008, , Revision: 8, Authorised, Last updated: 12/05/2020
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Human medicine European public assessment report (EPAR): Adakveo

Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020, , , , 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, , , , 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): 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): 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): Alsitek

Masitinib mesilate, Amyotrophic Lateral Sclerosis
Date of refusal: 26/07/2018, , Refused, Last updated: 31/07/2018
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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

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): Aplidin

,
Last updated: 26/11/2020
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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