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Human medicine European public assessment report (EPAR): Byfavo
remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,,
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, Revision: 2, Authorised, Last updated: 05/10/2022
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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: 5, Authorised, Last updated: 05/01/2023
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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): Calquence (updated)
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Revision: 4, Authorised, Last updated: 06/03/2023
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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): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
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, Revision: 1, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,,
, Revision: 7, Authorised, Last updated: 24/02/2023
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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: 30/01/2023
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Human medicine European public assessment report (EPAR): Cerdelga
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,,
, Revision: 13, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Cevenfacta
Eptacog beta (activated), Hemophilia A; Hemophilia B
Date of authorisation: 15/07/2022,, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,,
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, Revision: 5, Authorised, Last updated: 15/12/2021
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Human medicine European public assessment report (EPAR): Cibinqo (updated)
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,,
, Revision: 3, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Cinryze
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 23, Authorised, Last updated: 10/10/2022
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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: 41, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Copiktra
duvelisib, Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular
Date of authorisation: 19/05/2021,, Revision: 2, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 5, Authorised, Last updated: 17/02/2023
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia
Date of authorisation: 19/02/2018,,
, Revision: 10, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Cyltezo
adalimumab, Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 10/11/2017,,
, Revision: 2, Withdrawn, Last updated: 06/03/2019
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Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 21/03/2007,, Withdrawn, Last updated: 02/07/2013
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Human medicine European public assessment report (EPAR): Daurismo
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,,
, Revision: 4, Authorised, Last updated: 07/07/2021
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Human medicine European public assessment report (EPAR): Daxas
roflumilast, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 05/07/2010,, Revision: 19, Authorised, Last updated: 25/08/2022
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Human medicine European public assessment report (EPAR): Dectova
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,,
, Revision: 4, Authorised, Last updated: 08/10/2021
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,,
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, Revision: 14, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Delstrigo
doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 22/11/2018,, Revision: 10, Authorised, Last updated: 20/02/2023