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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

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Human medicine European public assessment report (EPAR): Benlysta (updated)

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 29, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Beovu (updated)

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 6, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Besremi (updated)

ropeginterferon alfa-2b, Polycythemia Vera
Date of authorisation: 15/02/2019, , Revision: 4, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Beyfortus (updated)

nirsevimab,
Date of authorisation: 31/10/2022, , Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Bimzelx

bimekizumab, Psoriasis
Date of authorisation: 20/08/2021, , Revision: 2, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): BindRen

colestilan, Hyperphosphatemia
Date of authorisation: 21/01/2013, , Revision: 2, Withdrawn, Last updated: 01/04/2015
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Human medicine European public assessment report (EPAR): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 4, Authorised, Last updated: 12/10/2022
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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: 15, Authorised, Last updated: 22/09/2022
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Human medicine European public assessment report (EPAR): Braftovi

Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018, , Revision: 10, Authorised, Last updated: 05/08/2022
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Human medicine European public assessment report (EPAR): Bretaris Genuair (updated)

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, , Authorised, Last updated: 20/05/2022
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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: 13, Authorised, Last updated: 04/01/2023
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Human medicine European public assessment report (EPAR): Brineura

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Brukinsa

zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021, , Revision: 4, Authorised, Last updated: 16/12/2022
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Human medicine European public assessment report (EPAR): Byfavo (updated)

remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021, , Revision: 3, Authorised, Last updated: 06/01/2023
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Human medicine European public assessment report (EPAR): Byooviz (updated)

ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021, , , Revision: 5, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Cablivi

Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018, , , Revision: 6, Authorised, Last updated: 26/07/2022
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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: 3, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Caprelsa

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , , Revision: 22, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Carvykti (updated)

ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022, , , , Revision: 1, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)

pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019, , , Revision: 6, Authorised, Last updated: 05/11/2021
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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): Cerdelga

eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015, , , Revision: 13, Authorised, Last updated: 11/01/2022
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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)

Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017, , , , Revision: 5, Authorised, Last updated: 15/12/2021