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Human medicine European public assessment report (EPAR): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,
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, Revision: 1, Authorised, Last updated: 24/04/2023
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Human medicine European public assessment report (EPAR): Uplizna
Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022,, Revision: 2, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 7, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Lunsumio
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , 
, Revision: 1, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 5, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Wakix
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 14, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, 
, Revision: 9, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Pluvicto
lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022,, Revision: 2, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,, 
, Revision: 12, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 11, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Byfavo
remimazolam besilate, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , , Revision: 4, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 6, Authorised, Last updated: 17/04/2023
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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: 23, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 3, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, , Revision: 6, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Zeposia
ozanimod hydrochloride, Multiple Sclerosis, Relapsing-Remitting; Colitis, Ulcerative
Date of authorisation: 20/05/2020,, Revision: 5, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Enjaymo
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,, , Revision: 2, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Hemgenix
Etranacogene dezaparvovec, Hemophilia B
Date of authorisation: 20/02/2023,, , , Revision: 1, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Qdenga
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue
Date of authorisation: 05/12/2022,, Authorised, Last updated: 12/04/2023
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Human medicine European public assessment report (EPAR): Aybintio
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: 19/08/2020,, , Revision: 7, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Onbevzi
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: 11/01/2021,, , Revision: 4, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Bimervax
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,, Authorised, Last updated: 05/04/2023
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Human medicine European public assessment report (EPAR): Upstaza
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Revision: 4, Authorised, Last updated: 05/04/2023