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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,
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, Revision: 7, Authorised, Last updated: 16/08/2019
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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018,, , Revision: 6, Authorised, Last updated: 14/08/2019
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, , Revision: 7, Authorised, Last updated: 06/08/2019
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Human medicine European public assessment report (EPAR): Ogivri (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 2, Authorised, Last updated: 05/08/2019
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Human medicine European public assessment report (EPAR): Kanjinti (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018,, , Revision: 5, Authorised, Last updated: 05/08/2019
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Human medicine European public assessment report (EPAR): Inflectra (updated)
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 09/09/2013,, Revision: 22, Authorised, Last updated: 05/08/2019
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Human medicine European public assessment report (EPAR): Halimatoz (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 4, Authorised, Last updated: 01/08/2019
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Human medicine European public assessment report (EPAR): Ovaleap (updated)
follitropin alfa, Anovulation
Date of authorisation: 27/09/2013,, Revision: 8, Authorised, Last updated: 31/07/2019
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, , Revision: 9, Authorised, Last updated: 31/07/2019
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Human medicine European public assessment report (EPAR): Kromeya (updated)
adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease
Date of authorisation: 02/04/2019,, , Revision: 1, Authorised, Last updated: 29/07/2019
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Human medicine European public assessment report (EPAR): Inhixa (updated)
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,, , Revision: 11, Authorised, Last updated: 24/07/2019
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Human medicine European public assessment report (EPAR): Filgrastim Hexal
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 06/02/2009,, Revision: 15, Authorised, Last updated: 09/07/2019
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Human medicine European public assessment report (EPAR): Zarzio
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 06/02/2009,, Revision: 16, Authorised, Last updated: 09/07/2019
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Human medicine European public assessment report (EPAR): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,, , Revision: 3, Authorised, Last updated: 08/07/2019
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Human medicine European public assessment report (EPAR): Rituzena (previously Tuxella)
rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 7, Withdrawn, Last updated: 08/07/2019
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Human medicine European public assessment report (EPAR): Riximyo
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 15/06/2017,, , Revision: 3, Authorised, Last updated: 04/07/2019
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Human medicine European public assessment report (EPAR): Movymia
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, , Revision: 5, Authorised, Last updated: 19/06/2019
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi
insulin lispro, Diabetes Mellitus
Date of authorisation: 18/07/2017,, , Revision: 4, Authorised, Last updated: 17/06/2019
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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): Mvasi
bevacizumab, Carcinoma, Renal Cell, Peritoneal Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018,, , Revision: 4, Authorised, Last updated: 13/06/2019
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Human medicine European public assessment report (EPAR): Truxima
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Wegener Granulomatosis, Leukemia, Lymphocytic, Chronic, B-Cell, Microscopic Polyangiitis
Date of authorisation: 17/02/2017,, , Revision: 8, Authorised, Last updated: 13/06/2019
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Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, , Revision: 3, Authorised, Last updated: 12/06/2019
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Human medicine European public assessment report (EPAR): Flixabi
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,, , Revision: 9, Authorised, Last updated: 11/06/2019
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Human medicine European public assessment report (EPAR): Nivestim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 07/06/2010,, Revision: 19, Authorised, Last updated: 04/06/2019
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Human medicine European public assessment report (EPAR): Hulio
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 16/09/2018,, , Revision: 2, Authorised, Last updated: 21/05/2019