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Human medicine European public assessment report (EPAR): Beyfortus
nirsevimab,
Date of authorisation: 31/10/2022,, Revision: 3, Authorised, Last updated: 23/06/2023
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Human medicine European public assessment report (EPAR): Bimervax (updated)
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,, Revision: 2, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Bimzelx
bimekizumab, Psoriasis
Date of authorisation: 20/08/2021,, Revision: 4, Authorised, Last updated: 04/07/2023
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
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, Revision: 6, Authorised, Last updated: 09/06/2023
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Human medicine European public assessment report (EPAR): Blincyto
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,,
, Revision: 17, Authorised, Last updated: 08/05/2023
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Human medicine European public assessment report (EPAR): Bretaris Genuair
aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012,, Revision: 18, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Breyanzi
CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022,, Revision: 1, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Brimica Genuair (updated)
formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,, Revision: 14, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,,
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, Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Briumvi
Ublituximab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 31/05/2023,, Authorised, Last updated: 13/07/2023
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Human medicine European public assessment report (EPAR): Brukinsa
zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021,, Revision: 6, Authorised, Last updated: 25/07/2023
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Human medicine European public assessment report (EPAR): Byfavo
remimazolam besilate, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 6, Authorised, Last updated: 16/06/2023
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Human medicine European public assessment report (EPAR): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,,
, Revision: 6, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Calquence
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Revision: 6, Authorised, Last updated: 15/06/2023
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Human medicine European public assessment report (EPAR): Camzyos
Mavacamten, Cardiomyopathy, Hypertrophic
Date of authorisation: 26/06/2023,, Revision: 1, Authorised, Last updated: 07/08/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
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, Revision: 4, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,,
, Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,,
, Revision: 12, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Cerdelga (updated)
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,,
, Revision: 16, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Cevenfacta
Eptacog beta (activated), Hemophilia A; Hemophilia B
Date of authorisation: 15/07/2022,, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,,
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, Revision: 6, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Cibinqo
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,,
, Revision: 5, Authorised, Last updated: 30/06/2023
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Human medicine European public assessment report (EPAR): Cinryze
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 23, Authorised, Last updated: 10/10/2022
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Human medicine European public assessment report (EPAR): Columvi
Glofitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 07/07/2023,,
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, Authorised, Last updated: 18/07/2023
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,,
, Revision: 44, Authorised, Last updated: 11/09/2023