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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,,
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, 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
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,,
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, Revision: 6, Authorised, Last updated: 15/03/2023
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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: 40, Authorised, Last updated: 15/03/2023
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,,
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, Revision: 6, Authorised, Last updated: 14/03/2023
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Human medicine European public assessment report (EPAR): Cablivi (updated)
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,,
, Revision: 7, Authorised, Last updated: 14/03/2023
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Human medicine European public assessment report (EPAR): Ebvallo (updated)
Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022,,
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, Revision: 2, Authorised, Last updated: 10/03/2023
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Human medicine European public assessment report (EPAR): Ronapreve (updated)
casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 3, Authorised, Last updated: 10/03/2023
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Human medicine European public assessment report (EPAR): Caprelsa (updated)
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, Revision: 24, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Rizmoic (updated)
Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019,, Revision: 8, Authorised, Last updated: 09/03/2023
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Human medicine European public assessment report (EPAR): Fetcroja (updated)
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 5, Authorised, Last updated: 08/03/2023