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38 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, Revision: 6, Withdrawn, Last updated: 29/09/2023
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,
, Revision: 8, Withdrawn, Last updated: 13/09/2023
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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, Withdrawn, Last updated: 20/04/2023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): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, 
, , Revision: 5, Withdrawn, Last updated: 30/11/2022
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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Date of authorisation: 24/09/2020,, , Revision: 3, Withdrawn, Last updated: 25/11/2021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Date of authorisation: 13/07/2017,, , Revision: 8, Withdrawn, Last updated: 16/08/2021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): Prepandrix
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
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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Date of authorisation: 21/09/2018,, , Revision: 3, Withdrawn, Last updated: 15/02/2021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): Kolbam
cholic acid, Metabolism, Inborn Errors
Date of authorisation: 20/11/2015,, Revision: 14, Withdrawn, Last updated: 15/07/2020
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Veterinary medicine European public assessment report (EPAR): Zulvac 1 Ovis
inactivated bluetongue virus, serotype-1, Sheep
Date of authorisation: 05/08/2011,, Revision: 6, Withdrawn, Last updated: 01/04/2020
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Veterinary medicine European public assessment report (EPAR): Zulvac 1 Bovis
inactivated bluetongue virus, serotype 1, Cattle
Date of authorisation: 05/08/2011,, Revision: 7, Withdrawn, Last updated: 30/03/2020
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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): Zalmoxis
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2), Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
Date of authorisation: 18/08/2016,, Revision: 1, Withdrawn, Last updated: 14/02/2020
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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): Lartruvo
Olaratumab, Sarcoma
Date of authorisation: 09/11/2016,, , , Revision: 3, Withdrawn, Last updated: 02/09/2019
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Human medicine European public assessment report (EPAR): Daklinza
daclatasvir dihydrochloride, Hepatitis C, Chronic
Date of authorisation: 22/08/2014,, Revision: 15, Withdrawn, Last updated: 30/08/2019
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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): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,, , Revision: 16, Withdrawn, Last updated: 02/07/2019
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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): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,, , Revision: 8, Withdrawn, Last updated: 30/10/2017
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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): Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) , Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 04/03/2011,, Revision: 4, Withdrawn, Last updated: 17/03/2015