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European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter Summaries of opinion (16) Apply Summaries of opinion filter Withdrawn applications (17) Apply Withdrawn applications filter Orphan designations (123) Apply Orphan designations filter Direct healthcare professional communication (41) Apply Direct healthcare professional communication filter

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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine Referrals Remove Referrals filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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List item

Human medicine European public assessment report (EPAR): Atriance

nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007, , , Revision: 26, Authorised, Last updated: 16/01/2023
List item

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Date of authorisation: 28/07/2006, , , Revision: 16, Withdrawn, Last updated: 02/07/2019
List item

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: 7, Authorised, Last updated: 11/04/2023
List item

Human medicine European public assessment report (EPAR): Ayvakyt

Avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020, , , , Revision: 7, Authorised, Last updated: 28/06/2023
List item

Human medicine European public assessment report (EPAR): Bavencio

avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017, , Revision: 16, Authorised, Last updated: 30/08/2023
List item

Human medicine European public assessment report (EPAR): Bekemv

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 19/04/2023, , Revision: 1, Authorised, Last updated: 06/07/2023
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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

etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016, , Revision: 21, Authorised, Last updated: 14/09/2023
List item

Human medicine European public assessment report (EPAR): Benlysta

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 31, Authorised, Last updated: 31/10/2023
List item

Human medicine European public assessment report (EPAR): Beovu

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 10, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Besremi

ropeginterferon alfa-2b, Polycythemia Vera
Date of authorisation: 15/02/2019, , Revision: 4, Authorised, Last updated: 25/01/2023
List item

Human medicine European public assessment report (EPAR): Beyfortus

nirsevimab,
Date of authorisation: 31/10/2022, , Revision: 3, Authorised, Last updated: 23/06/2023
List item

Human medicine European public assessment report (EPAR): Bimervax

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
List item

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

bimekizumab, Psoriasis
Date of authorisation: 20/08/2021, , Revision: 5, Authorised, Last updated: 13/11/2023
List item

Human medicine European public assessment report (EPAR): BindRen

colestilan, Hyperphosphatemia
Date of authorisation: 21/01/2013, , Revision: 2, Withdrawn, Last updated: 01/04/2015
List item

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

epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007, , Revision: 22, Authorised, Last updated: 21/11/2023
List item

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
List item

Human medicine European public assessment report (EPAR): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 7, Authorised, Last updated: 25/10/2023
List item

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

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 18, Authorised, Last updated: 24/11/2023
List item

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: 19, Authorised, Last updated: 29/11/2023
List item

Veterinary medicine European public assessment report (EPAR): Bluevac BTV (previously known as Bluevac BTV8)

bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated], Sheep; Cattle
Date of authorisation: 14/04/2011, , Revision: 7, Authorised, Last updated: 27/10/2020
List item

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
List item

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: 2, Authorised, Last updated: 11/10/2023
List item

Human medicine European public assessment report (EPAR): Brimica Genuair

formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014, , Revision: 14, Authorised, Last updated: 26/09/2023
List item

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