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Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 8, Authorised, Last updated: 11/05/2023
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, COVID-19 virus infection
Date of authorisation: 03/07/2020,, Revision: 18, Authorised, Last updated: 11/05/2023
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,,
, Revision: 14, Authorised, Last updated: 10/05/2023
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Human medicine European public assessment report (EPAR): Kymriah (updated)
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, Revision: 14, Authorised, Last updated: 10/05/2023
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Human medicine European public assessment report (EPAR): Vegzelma (updated)
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: 17/08/2022,,
, Revision: 3, Authorised, Last updated: 10/05/2023
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Human medicine European public assessment report (EPAR): Deferasirox Accord (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 08/05/2023
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Human medicine European public assessment report (EPAR): Padcev (updated)
Enfortumab vedotin, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 13/04/2022,, Revision: 1, Authorised, Last updated: 08/05/2023
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,,
, Revision: 17, Authorised, Last updated: 08/05/2023
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Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,,
, Revision: 16, Authorised, Last updated: 08/05/2023
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Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, Revision: 11, Authorised, Last updated: 04/05/2023
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Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 12, Withdrawn, Last updated: 04/05/2023
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Human medicine European public assessment report (EPAR): Luxturna (updated)
voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018,,
, Revision: 6, Authorised, Last updated: 04/05/2023
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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: 5, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Rybelsus (updated)
semaglutide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2020,, Revision: 5, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Ozempic (updated)
semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018,, Revision: 10, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Xenpozyme (updated)
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,,
, Revision: 1, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,,
, Revision: 14, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,,
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, Revision: 16, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Zynlonta (updated)
loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022,,
, Revision: 2, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 4, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Yselty (updated)
linzagolix choline, Leiomyoma
Date of authorisation: 14/06/2022,, Revision: 3, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Imfinzi (updated)
durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018,, Revision: 16, Authorised, Last updated: 02/05/2023
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,,
, Revision: 20, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): Palynziq (updated)
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,,
, Revision: 7, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 35, Authorised, Last updated: 28/04/2023