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754 results
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Human medicine European public assessment report (EPAR): Regkirona (updated)
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,
, Revision: 8, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, Revision: 10, Authorised, Last updated: 24/08/2023
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, COVID-19 virus infection
Date of authorisation: 03/07/2020,, Revision: 21, Authorised, Last updated: 24/08/2023
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Human medicine European public assessment report (EPAR): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 8, Authorised, Last updated: 23/08/2023
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Human medicine European public assessment report (EPAR): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,, 
, Revision: 2, Authorised, Last updated: 23/08/2023
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Human medicine European public assessment report (EPAR): Tecovirimat SIGA
Tecovirimat, Poxviridae Infections; Cowpox; Monkeypox; Vaccinia; Smallpox
Date of authorisation: 06/01/2022,, Revision: 2, Authorised, Last updated: 23/08/2023
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , 
, Revision: 5, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Tukysa
Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021,, Revision: 5, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , , Revision: 6, Withdrawn, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Evusheld
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 3, Authorised, Last updated: 18/08/2023
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Human medicine European public assessment report (EPAR): Nexpovio
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,, Revision: 8, Authorised, Last updated: 17/08/2023
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Human medicine European public assessment report (EPAR): Tezspire
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 6, Authorised, Last updated: 16/08/2023
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Human medicine European public assessment report (EPAR): Aimovig
erenumab, Migraine Disorders
Date of authorisation: 26/07/2018,, Revision: 11, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 25, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Mayzent
Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020,, Revision: 10, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Evenity
Romosozumab, Osteoporosis
Date of authorisation: 09/12/2019,, Revision: 4, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Refixia
Nonacog beta pegol, Hemophilia B
Date of authorisation: 02/06/2017,, Revision: 4, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Zabdeno
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: 4, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Mvabea
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Revision: 3, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Trodelvy
Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms
Date of authorisation: 22/11/2021,, Revision: 3, Authorised, Last updated: 11/08/2023
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Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , , Revision: 25, Authorised, Last updated: 09/08/2023
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Human medicine European public assessment report (EPAR): Plerixafor Accord
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022,, 
, Revision: 1, Authorised, Last updated: 07/08/2023
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Human medicine European public assessment report (EPAR): Camzyos
Mavacamten, Cardiomyopathy, Hypertrophic
Date of authorisation: 26/06/2023,, Revision: 1, Authorised, Last updated: 07/08/2023
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Human medicine European public assessment report (EPAR): Flucelvax Tetra
A/Darwin/6/2021(H3N2)-like strain (A/Darwin/11/2021, wild type) / A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) / B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021) / B/Phuket/3073/2013-like virus (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 14, Authorised, Last updated: 07/08/2023
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Human medicine European public assessment report (EPAR): Fluad Tetra
A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/6/2021, IVR-227) / A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) / Influenza virus B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26), Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 7, Authorised, Last updated: 04/08/2023