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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

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: 17/08/2022, , , Revision: 2, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Polivy (updated)

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 5, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Zynlonta (updated)

loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022, , , Revision: 1, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Blincyto (updated)

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 16, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): PreHevbri (updated)

hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022, , Revision: 1, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi (updated)

insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017, , Revision: 8, Authorised, Last updated: 22/03/2023
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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: 19, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Ultomiris (updated)

ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019, , Revision: 10, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Imcivree (updated)

Setmelanotide, Obesity
Date of authorisation: 16/07/2021, , , Revision: 7, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Vihuma (updated)

simoctocog alfa, Hemophilia A
Date of authorisation: 13/02/2017, , Revision: 8, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Beyfortus (updated)

nirsevimab,
Date of authorisation: 31/10/2022, , Revision: 1, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Inrebic (updated)

fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021, , , Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Vydura (updated)

Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022, , Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)

A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018, , Revision: 12, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Imvanex (updated)

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013, , , Revision: 24, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Reblozyl (updated)

Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020, , , Revision: 4, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Nubeqa (updated)

darolutamide, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 27/03/2020, , Revision: 4, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Isturisa (updated)

Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020, , , Revision: 4, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , Revision: 27, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Erleada (updated)

apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019, , Revision: 9, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Quviviq (updated)

daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/04/2022, , Revision: 4, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Evoltra (updated)

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 32, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Livtencity (updated)

Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022, , , Revision: 3, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 10, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Zabdeno (updated)

Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020, , , Revision: 3, Authorised, Last updated: 17/03/2023