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Human medicine European public assessment report (EPAR): Livmarli (updated)
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,
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, Revision: 1, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Evoltra (updated)
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,, , Revision: 33, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,
, Revision: 16, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Tevagrastim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 17, Authorised, Last updated: 24/05/2023
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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, , Revision: 8, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Nivestim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010,, Revision: 27, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 2, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 13, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 13, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Fingolimod Accord (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 25/06/2020,, Revision: 3, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Ritonavir Mylan (updated)
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 14, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Atazanavir Mylan (updated)
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,, Revision: 14, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma (updated)
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Febuxostat Mylan (updated)
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,, Revision: 11, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Sirturo (updated)
bedaquiline fumarate, Tuberculosis, Multidrug-Resistant
Date of authorisation: 05/03/2014,, , 
, Revision: 21, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Bekemv (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 19/04/2023,, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Rozlytrek (updated)
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, , Revision: 6, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka (updated)
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 10, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Retsevmo (updated)
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,, , Revision: 6, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Bylvay (updated)
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,
, , , Revision: 2, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 5, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Febuxostat Krka (updated)
febuxostat, Hyperuricemia; Gout
Date of authorisation: 28/03/2019,, Revision: 4, Authorised, Last updated: 11/05/2023
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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): 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