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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion filter

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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, , , , 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, , , , 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
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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: 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, , , , Revision: 7, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Duaklir Genuair

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, , , , Revision: 2, Authorised, Last updated: 10/03/2023
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Human medicine European public assessment report (EPAR): Eklira Genuair

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 (updated)

tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021, , , , Revision: 6, Authorised, Last updated: 15/03/2023