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Categories Human Remove Human filter Veterinary Remove Veterinary filter

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

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

tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021, , , , Revision: 6, 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, , , , 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, , , , 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): Hukyndra (updated)

adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021, , Revision: 4, 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
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Human medicine European public assessment report (EPAR): Senshio (updated)

ospemifene, Postmenopause
Date of authorisation: 14/01/2015, , Revision: 13, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi) (updated)

Lusutrombopag, Thrombocytopenia
Date of authorisation: 18/02/2019, , Revision: 8, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Kauliv (updated)

teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 12/01/2023, , , Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Tevagrastim (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008, , Revision: 16, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Tecvayli (updated)

Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022, , , Authorised, Last updated: 07/03/2023