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Human medicine European public assessment report (EPAR): Tevagrastim (updated)
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,
, Revision: 11, Authorised, Last updated: 20/09/2019
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Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Arthritis, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 24/08/2017,
, , Revision: 10, Authorised, Last updated: 12/09/2019
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Human medicine European public assessment report (EPAR): Hyrimoz (updated)
adalimumab, Hidradenitis Suppurativa, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Skin Diseases, Papulosquamous, Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 4, Authorised, Last updated: 05/09/2019
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Human medicine European public assessment report (EPAR): Amgevita (updated)
adalimumab, Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,, , Revision: 6, Authorised, Last updated: 05/09/2019
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Human medicine European public assessment report (EPAR): Idacio (updated)
adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease
Date of authorisation: 02/04/2019,, , Revision: 1, Authorised, Last updated: 30/08/2019
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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016,, , Revision: 10, Authorised, Last updated: 27/08/2019
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Human medicine European public assessment report (EPAR): Pelgraz (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 3, Authorised, Last updated: 27/08/2019
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal (updated)
epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer
Date of authorisation: 27/08/2007,, Revision: 21, Authorised, Last updated: 27/08/2019
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Human medicine European public assessment report (EPAR): Ratiograstim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 10, Authorised, Last updated: 21/08/2019
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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: 7, Authorised, Last updated: 16/08/2019
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Human medicine European public assessment report (EPAR): Herzuma
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
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
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
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
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
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
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
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
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
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