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36 results
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
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, Revision: 6, Withdrawn, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Omblastys
iodine (131I) omburtamab, Neuroblastoma
Date of refusal: 12/04/2023,, Refused, Last updated: 14/06/2023
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Human medicine European public assessment report (EPAR): Inpremzia
insulin human (rDNA), Diabetes Mellitus
Date of authorisation: 25/04/2022,,
, Withdrawn, Last updated: 20/04/2023
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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, Revision: 3, Withdrawn, Last updated: 25/11/2021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): 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, Revision: 8, Withdrawn, Last updated: 16/08/2021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): Gamifant
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,, Refused, Last updated: 23/03/2021
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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, Revision: 3, Withdrawn, Last updated: 15/02/2021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, Revision: 8, Withdrawn, Last updated: 29/01/2021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): 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): Thorinane
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 14/09/2016,,
, Revision: 2, Withdrawn, Last updated: 24/10/2019
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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): Cyltezo
adalimumab, Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 10/11/2017,,
, Revision: 2, Withdrawn, Last updated: 06/03/2019
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Human medicine European public assessment report (EPAR): Solymbic
adalimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,,
, Revision: 2, Withdrawn, Last updated: 05/03/2019
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Human medicine European public assessment report (EPAR): Lusduna
insulin glargine, Diabetes Mellitus
Date of authorisation: 03/01/2017,, Revision: 2, Withdrawn, Last updated: 22/01/2019
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Human medicine European public assessment report (EPAR): Alsitek
Masitinib mesilate, Amyotrophic Lateral Sclerosis
Date of refusal: 26/07/2018,, Refused, Last updated: 31/07/2018
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Human medicine European public assessment report (EPAR): Masipro
Masitinib mesilate, Mastocytosis
Date of refusal: 18/12/2017,, Refused, Last updated: 04/04/2018
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Human medicine European public assessment report (EPAR): Biograstim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 8, Withdrawn, Last updated: 19/01/2017
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Human medicine European public assessment report (EPAR): Dropcys
mercaptamine, Corneal Diseases; Cystinosis
Date of refusal: 24/06/2016,, Refused, Last updated: 25/07/2016
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Human medicine European public assessment report (EPAR): Heparesc
Human heterologous liver cells, Urea Cycle Disorders, Inborn
Date of refusal: 21/12/2015,, Refused, Last updated: 04/04/2016
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Human medicine European public assessment report (EPAR): Solumarv
insulin human, Diabetes Mellitus
Date of refusal: 11/02/2016,, Refused, Last updated: 16/02/2016
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Human medicine European public assessment report (EPAR): Lympreva
dasiprotimut-t, Lymphoma, Non-Hodgkin
Date of refusal: 03/07/2015,, Refused, Last updated: 17/07/2015
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Human medicine European public assessment report (EPAR): Masiviera
masitinib, Pancreatic Neoplasms, Refused, Last updated: 06/01/2015
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Human medicine European public assessment report (EPAR): Masican
masitinib, Gastrointestinal Stromal Tumors
Date of refusal: 04/07/2014,, Refused, Last updated: 22/11/2013
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Human medicine European public assessment report (EPAR): Istodax
romidepsin, Lymphoma, Non-Hodgkin
Date of refusal: 12/02/2013,, Refused, Last updated: 14/03/2013
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Human medicine European public assessment report (EPAR): Elelyso
Taliglucerase alfa, Gaucher Disease
Date of refusal: 25/10/2012,, Refused, Last updated: 23/11/2012