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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
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,,
, Revision: 2, Authorised, Last updated: 11/10/2022
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Human medicine European public assessment report (EPAR): Cinqaero
Reslizumab, Asthma
Date of authorisation: 15/08/2016,, Revision: 10, Authorised, Last updated: 18/11/2021
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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: 38, Authorised, Last updated: 02/02/2023
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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: 4, Authorised, Last updated: 05/12/2022
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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): 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: 13, Authorised, Last updated: 28/01/2021
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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: 9, Authorised, Last updated: 11/10/2022
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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: 22, Authorised, Last updated: 18/10/2022
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Human medicine European public assessment report (EPAR): Dengvaxia
chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated), Dengue
Date of authorisation: 12/12/2018,, Revision: 3, Authorised, Last updated: 26/01/2022
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Human medicine European public assessment report (EPAR): Doptelet
avatrombopag maleate, Thrombocytopenia
Date of authorisation: 20/06/2019,, Revision: 5, Authorised, Last updated: 20/06/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,,
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, Revision: 6, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Duaklir Genuair (updated)
aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,, Revision: 15, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Duzallo
allopurinol, lesinurad, Gout
Date of authorisation: 23/08/2018,, Revision: 2, Withdrawn, Last updated: 06/08/2020
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Human medicine European public assessment report (EPAR): Ebvallo (updated)
Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022,,
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, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Eklira Genuair (updated)
aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012,, Revision: 20, Authorised, Last updated: 11/01/2023
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Human medicine European public assessment report (EPAR): Eladynos
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 25, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,,
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, Revision: 5, Authorised, Last updated: 23/09/2022