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567 results
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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,
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, Revision: 2, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 13, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Heplisav B (updated)
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 18/02/2021,, Revision: 3, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 30, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Ajovy (updated)
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 9, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 6, Authorised, Last updated: 22/05/2023
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Human medicine European public assessment report (EPAR): Eladynos (updated)
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis, Revision: 1, Authorised, Last updated: 22/05/2023
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Human medicine European public assessment report (EPAR): Ibrance (updated)
Palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 15, Authorised, Last updated: 22/05/2023
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Human medicine European public assessment report (EPAR): Kanuma (updated)
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, 
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, Revision: 9, Authorised, Last updated: 17/05/2023
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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): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, Revision: 15, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, Revision: 14, 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): Xofigo (updated)
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 13, Authorised, Last updated: 16/05/2023
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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): Imnovid (previously Pomalidomide Celgene) (updated)
Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013,, , Revision: 22, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
, , Revision: 28, Authorised, Last updated: 12/05/2023
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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): Evusheld (updated)
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 2, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)
pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021,, Revision: 4, 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): Tibsovo (updated)
Ivosidenib, Leukemia, Myeloid, Acute; Cholangiocarcinoma
Date of authorisation: 04/05/2023,, , 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): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 18, 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