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208 results
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,
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, Revision: 11, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Ondexxya
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, 
, Revision: 8, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Inhixa
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Remsima
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 22, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Benepali
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, Revision: 13, Authorised, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Nepexto
etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020,, , Revision: 3, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 7, Authorised, Last updated: 22/02/2021
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, 
, , Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Udenyca
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 3, Withdrawn, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Ritemvia
rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 8, Authorised, Last updated: 11/02/2021
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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: 10, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Ontruzant
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, , Revision: 8, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,, Revision: 1, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Bosulif
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013,, , Revision: 20, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , 
, Revision: 13, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, 
, , , Revision: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 5, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, , Revision: 13, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 8, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Holoclar
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 7, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Livogiva
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, , Revision: 1, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Zirabev
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 7, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Erelzi
etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, , Revision: 8, Authorised, Last updated: 04/01/2021
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Human medicine European public assessment report (EPAR): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, , Revision: 4, Authorised, Last updated: 22/12/2020