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Human medicine European public assessment report (EPAR): Truxima (updated)
rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Wegener Granulomatosis, Leukemia, Lymphocytic, Chronic, B-Cell, Microscopic Polyangiitis
Date of authorisation: 17/02/2017,
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, Revision: 9, Authorised, Last updated: 11/10/2019
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Human medicine European public assessment report (EPAR): Pelmeg (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 1, Authorised, Last updated: 11/10/2019
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Human medicine European public assessment report (EPAR): Filgrastim Hexal (updated)
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 06/02/2009,, Revision: 16, Authorised, Last updated: 10/10/2019
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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: 22, Authorised, Last updated: 09/10/2019
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Human medicine European public assessment report (EPAR): Nivestim (updated)
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 07/06/2010,, Revision: 20, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Abseamed (updated)
epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Zarzio (updated)
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 06/02/2009,, Revision: 17, Authorised, Last updated: 08/10/2019
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, , Revision: 4, Authorised, Last updated: 07/10/2019
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Human medicine European public assessment report (EPAR): Trazimera (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 26/07/2018,, , Revision: 3, Authorised, Last updated: 07/10/2019
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 16, Authorised, Last updated: 03/10/2019
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Human medicine European public assessment report (EPAR): Ovaleap (updated)
follitropin alfa, Anovulation
Date of authorisation: 27/09/2013,, Revision: 9, Authorised, Last updated: 03/10/2019
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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: 2, Authorised, Last updated: 03/10/2019
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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
Date of authorisation: 15/06/2017,, , Revision: 3, Authorised, Last updated: 03/10/2019
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Human medicine European public assessment report (EPAR): Hefiya (updated)
adalimumab, Hidradenitis Suppurativa, Spondylitis, Ankylosing, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis
Date of authorisation: 26/07/2018,, , Revision: 4, Authorised, Last updated: 02/10/2019
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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, , Revision: 2, Authorised, Last updated: 02/10/2019
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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: 23, Authorised, Last updated: 02/10/2019
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Human medicine European public assessment report (EPAR): Ritemvia (updated)
rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 13/07/2017,, , Revision: 7, Authorised, Last updated: 01/10/2019
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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
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
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
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
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
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
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): Ratiograstim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 10, Authorised, Last updated: 21/08/2019