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List item

Human medicine European public assessment report (EPAR): Livmarli (updated)

Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022, , , , 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): 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): 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): Remsima (updated)

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 34, Authorised, Last updated: 17/05/2023
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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
List item

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
List item

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): 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): 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): 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): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , 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): Translarna

Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014, , , , Revision: 22, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Lunsumio

mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022, , , , Revision: 1, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Inpremzia

insulin human (rDNA), Diabetes Mellitus
Date of authorisation: 25/04/2022, , , Withdrawn, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Pelgraz

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , , Revision: 9, Authorised, Last updated: 20/04/2023
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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: 19/04/2023
List item

Human medicine European public assessment report (EPAR): Alymsys

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 5, Authorised, Last updated: 18/04/2023