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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: 12, Authorised, Last updated: 24/09/2021
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Human medicine European public assessment report (EPAR): Abevmy
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 21/04/2021,,
, Revision: 5, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Abiraterone Accord
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Abiraterone Krka
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Abiraterone Mylan (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 4, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Abrysvo (updated)
Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023,,
, Authorised, Last updated: 15/09/2023
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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: 21/08/2023
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 14, Authorised, Last updated: 24/07/2023
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Human medicine European public assessment report (EPAR): Actelsar HCT
Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 15, Authorised, Last updated: 01/06/2023
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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): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,,
, Revision: 6, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 4, Authorised, Last updated: 26/04/2023
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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: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Amifampridine SERB
amifampridine phosphate, Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms
Date of authorisation: 19/05/2022,, Authorised, Last updated: 24/05/2022
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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: 11, Authorised, Last updated: 17/08/2023
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Human medicine European public assessment report (EPAR): Amsparity
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 13/02/2020,,
, Revision: 4, Authorised, Last updated: 29/10/2021
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Human medicine European public assessment report (EPAR): Amversio
betaine, Homocystinuria
Date of authorisation: 05/05/2022,, Authorised, Last updated: 08/06/2023
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 8, Authorised, Last updated: 11/05/2023
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Human medicine European public assessment report (EPAR): Apixaban Accord
Apixaban, Venous Thromboembolism; Stroke; Arthroplasty
Date of authorisation: 23/07/2020,, Revision: 2, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 15, Authorised, Last updated: 13/07/2022
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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: 16, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 9, Authorised, Last updated: 01/09/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 9, Authorised, Last updated: 26/08/2022
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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: 5, Authorised, Last updated: 12/05/2022
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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,, Revision: 2, Authorised, Last updated: 26/04/2022