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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Withdrawn applications Remove Withdrawn applications filter

Medicine type Conditional approval Remove Conditional approval filter Biosimilar Remove Biosimilar filter Additional monitoring Remove Additional monitoring filter Exceptional circumstances Remove Exceptional circumstances filter

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Human medicine European public assessment report (EPAR): Artesunate Amivas

artesunate, Malaria
Date of authorisation: 22/11/2021, , , Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Aspaveli

Pegcetacoplan, Hemoglobinuria, Paroxysmal
Date of authorisation: 13/12/2021, , , Revision: 3, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Atriance (updated)

nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007, , , Revision: 26, Authorised, Last updated: 16/01/2023
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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Date of authorisation: 28/07/2006, , , Revision: 16, Withdrawn, Last updated: 02/07/2019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): Aybintio

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020, , , Revision: 6, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Ayvakyt

avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020, , , , Revision: 4, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Bavencio

avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017, , Revision: 14, Authorised, Last updated: 19/10/2022
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Human medicine European public assessment report (EPAR): Bemfola

follitropin alfa, Anovulation
Date of authorisation: 26/03/2014, , Revision: 10, Authorised, Last updated: 19/12/2022
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Human medicine European public assessment report (EPAR): Benepali (updated)

etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016, , Revision: 18, Authorised, Last updated: 06/01/2023
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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): Binocrit

epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007, , Revision: 20, Authorised, Last updated: 31/10/2019
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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): 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): Blitzima

rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017, , Revision: 17, Authorised, Last updated: 30/11/2022
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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