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Medicine
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Human medicine European public assessment report (EPAR): Cerdelga (updated)
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,
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, Revision: 16, Authorised, Last updated: 28/08/2023
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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,, 
, , Revision: 10, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Eladynos (updated)
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis
Date of authorisation: 12/12/2022,, Revision: 2, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET) (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 20/06/2022,
, Revision: 3, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Duloxetine Mylan (updated)
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 18, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 9, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Aquipta (updated)
atogepant, Migraine Disorders
Date of authorisation: 11/08/2023,, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Regkirona (updated)
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 8, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, Revision: 10, Authorised, Last updated: 24/08/2023
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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: 21, Authorised, Last updated: 24/08/2023
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Human medicine European public assessment report (EPAR): Tolucombi (updated)
Telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 13/03/2013,, Revision: 11, Authorised, Last updated: 24/08/2023
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Human medicine European public assessment report (EPAR): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 8, Authorised, Last updated: 23/08/2023
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Human medicine European public assessment report (EPAR): Artesunate Amivas (updated)
artesunate, Malaria
Date of authorisation: 22/11/2021,, , Revision: 2, Authorised, Last updated: 23/08/2023
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Human medicine European public assessment report (EPAR): Tecovirimat SIGA (updated)
Tecovirimat, Poxviridae Infections; Cowpox; Monkeypox; Vaccinia; Smallpox
Date of authorisation: 06/01/2022,, Revision: 2, Authorised, Last updated: 23/08/2023
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , 
, Revision: 5, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Tukysa
Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021,, Revision: 5, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , , Revision: 6, Withdrawn, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Sun
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 18, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Fingolimod Accord
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 25/06/2020,, Revision: 4, Authorised, Last updated: 18/08/2023
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Human medicine European public assessment report (EPAR): Evusheld
tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022,, Revision: 3, Authorised, Last updated: 18/08/2023
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Human medicine European public assessment report (EPAR): Nexpovio
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,, Revision: 8, Authorised, Last updated: 17/08/2023
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Human medicine European public assessment report (EPAR): Nemdatine
memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013,, Revision: 13, Authorised, Last updated: 17/08/2023
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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 11, Authorised, Last updated: 17/08/2023
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Human medicine European public assessment report (EPAR): Tezspire
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 6, Authorised, Last updated: 16/08/2023