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Medicine
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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): 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,,
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, 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): 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
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Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,,
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, Revision: 4, Authorised, Last updated: 01/08/2023
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Human medicine European public assessment report (EPAR): Sogroya
Somapacitan, Growth
Date of authorisation: 31/03/2021,,
, Revision: 2, Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Ztalmy
Ganaxolone, Epileptic Syndromes; Spasms, Infantile
Date of authorisation: 26/07/2023,,
, Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Omvoh
Mirikizumab, Colitis, Ulcerative
Date of authorisation: 26/05/2023,, Revision: 1, Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,,
, Revision: 6, Authorised, Last updated: 28/07/2023
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Human medicine European public assessment report (EPAR): Luxturna
voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018,,
, Revision: 7, Authorised, Last updated: 28/07/2023
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Human medicine European public assessment report (EPAR): Heplisav B
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 18/02/2021,, Revision: 4, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,,
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, Revision: 6, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Tecvayli
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,,
, Revision: 1, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Revestive
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,,
, Revision: 22, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Xofluza
Baloxavir marboxil, Influenza, Human
Date of authorisation: 07/01/2021,, Revision: 4, Authorised, Last updated: 27/07/2023