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229 results
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,
, Revision: 20, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Epysqli (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023,
, , Authorised, Last updated: 31/05/2023
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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: 35, Authorised, Last updated: 30/05/2023
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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: 15, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, 
, , Revision: 11, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 16, Authorised, Last updated: 30/05/2023
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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): 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): 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): 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): 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): 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
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): 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
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 11, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, Revision: 12, Authorised, Last updated: 18/04/2023