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Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Opsumit (updated)
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,
, Revision: 18, Authorised, Last updated: 18/06/2021
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Human medicine European public assessment report (EPAR): Palynziq (updated)
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,
, , Revision: 2, Authorised, Last updated: 17/06/2021
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Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,, 
, Revision: 4, Authorised, Last updated: 17/06/2021
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Human medicine European public assessment report (EPAR): Yuflyma (updated)
adalimumab, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease, Arthritis, Juvenile Rheumatoid, Hidradenitis Suppurativa, Uveitis
Date of authorisation: 11/02/2021,, Revision: 3, Authorised, Last updated: 17/06/2021
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Human medicine European public assessment report (EPAR): Ofev (updated)
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,
, Revision: 19, Authorised, Last updated: 17/06/2021
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Veterinary medicine European public assessment report (EPAR): Emdocam (updated)
meloxicam, Horses, Pigs, Cattle
Date of authorisation: 18/08/2011,
, Revision: 8, Authorised, Last updated: 16/06/2021
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Human medicine European public assessment report (EPAR): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Revision: 2, Authorised, Last updated: 16/06/2021
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Human medicine European public assessment report (EPAR): Vimizim (updated)
recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014,, , Revision: 12, Authorised, Last updated: 16/06/2021
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Human medicine European public assessment report (EPAR): Riximyo (updated)
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 15/06/2017,, , Revision: 5, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 13, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Rixathon (updated)
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 15/06/2017,, , Revision: 4, Authorised, Last updated: 15/06/2021
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 13, Authorised, Last updated: 11/06/2021
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Veterinary medicine European public assessment report (EPAR): Tulissin (updated)
tulathromycin, Cattle, Pigs, Sheep
Date of authorisation: 24/04/2020,, Revision: 2, Authorised, Last updated: 11/06/2021
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm (updated)
clopidogrel (as hydrogen sulfate), Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke
Date of authorisation: 18/02/2015,, Revision: 11, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , 
, Revision: 22, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Zalasta (updated)
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 27/09/2007,, Revision: 18, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Erelzi (updated)
etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, , Revision: 9, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 17, Authorised, Last updated: 10/06/2021
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Human medicine European public assessment report (EPAR): Hulio (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 17/09/2018,, , Revision: 6, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira) (updated)
voriconazole, Bacterial Infections and Mycoses, Aspergillosis, Candidiasis
Date of authorisation: 27/05/2015,, Revision: 9, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Nepexto (updated)
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 4, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 11, Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Inrebic (updated)
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders, Primary Myelofibrosis
Date of authorisation: 08/02/2021,, , Authorised, Last updated: 09/06/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/06/2021
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Human medicine European public assessment report (EPAR): Capecitabine Accord (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,
, , Revision: 14, Authorised, Last updated: 04/06/2021