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98 results
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Human medicine European public assessment report (EPAR): Semglee
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,
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, Revision: 6, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Grastofil
filgrastim, Neutropenia
Date of authorisation: 17/10/2013,, Revision: 14, Authorised, Last updated: 10/01/2022
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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: 10, Authorised, Last updated: 17/12/2021
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Human medicine European public assessment report (EPAR): Tevagrastim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 15, Authorised, Last updated: 08/12/2021
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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: 14, Authorised, Last updated: 06/12/2021
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Human medicine European public assessment report (EPAR): Retacrit
epoetin zeta, Anemia; Blood Transfusion, Autologous; Kidney Failure, Chronic; Cancer
Date of authorisation: 18/12/2007,, Revision: 29, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, , Revision: 3, Withdrawn, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): Pelmeg
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 6, Authorised, Last updated: 09/11/2021
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, , Revision: 6, Authorised, Last updated: 05/11/2021
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Human medicine European public assessment report (EPAR): Nyvepria
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, , Revision: 4, Authorised, Last updated: 05/11/2021
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Human medicine European public assessment report (EPAR): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,, , Revision: 5, Authorised, Last updated: 03/11/2021
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Human medicine European public assessment report (EPAR): Amsparity
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 13/02/2020,, , Revision: 4, Authorised, Last updated: 29/10/2021
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Human medicine European public assessment report (EPAR): Omnitrope
somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
Date of authorisation: 12/04/2006,, Revision: 19, Authorised, Last updated: 19/10/2021
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Human medicine European public assessment report (EPAR): Abseamed
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 14/10/2021
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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: 12, Authorised, Last updated: 24/09/2021
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 1, Authorised, Last updated: 14/09/2021
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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 7, Authorised, Last updated: 19/08/2021
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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, Withdrawn, Last updated: 16/08/2021
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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): 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): 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): Silapo
epoetin zeta, Anemia; Blood Transfusion, Autologous; Cancer; Kidney Failure, Chronic
Date of authorisation: 18/12/2007,, Revision: 17, Authorised, Last updated: 25/11/2020
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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: 4, Withdrawn, Last updated: 25/03/2020
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Human medicine European public assessment report (EPAR): Binocrit
epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 20, Authorised, Last updated: 31/10/2019
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Human medicine European public assessment report (EPAR): Thorinane
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 14/09/2016,, , Revision: 2, Withdrawn, Last updated: 24/10/2019