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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid; Crohn Disease; Psoriasis
Date of authorisation: 26/05/2016,
, Revision: 23, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,
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, Revision: 3, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)
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, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, Revision: 18, Authorised, Last updated: 02/02/2023
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,
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, Revision: 15, Authorised, Last updated: 01/02/2023
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (updated)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,, , Revision: 3, Authorised, Last updated: 31/01/2023
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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,, Revision: 19, Authorised, Last updated: 31/01/2023
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Human medicine European public assessment report (EPAR): Ceplene (updated)
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,, , Revision: 12, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Tecartus (updated)
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , , Revision: 4, Authorised, Last updated: 30/01/2023
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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: 20, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Yescarta (updated)
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 11, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Ranivisio (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022,, , Revision: 2, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Yuflyma (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021,, Revision: 9, Authorised, Last updated: 30/01/2023
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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: 21, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,, , Revision: 9, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, , Revision: 18, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): NexoBrid (updated)
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, , Revision: 14, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Trecondi (updated)
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,, Revision: 3, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Pelgraz (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, , Revision: 8, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Omnitrope (updated)
somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
Date of authorisation: 12/04/2006,, Revision: 21, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Filsuvez (updated)
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Revision: 1, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 15, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 23/01/2023
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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: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 11, Authorised, Last updated: 18/01/2023