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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

rilpivirine, HIV Infections
Date of authorisation: 17/12/2020, , Revision: 8, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Skyrizi (updated)

Risankizumab, Psoriasis; Arthritis, Psoriatic
Date of authorisation: 26/04/2019, , Revision: 16, Authorised, Last updated: 04/09/2023
List item

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

SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023, , Revision: 2, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Fintepla (updated)

Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020, , , Revision: 6, Authorised, Last updated: 01/09/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)

ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021, , , Revision: 5, Authorised, Last updated: 30/08/2023
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Human medicine European public assessment report (EPAR): Bavencio (updated)

avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017, , Revision: 16, Authorised, Last updated: 30/08/2023
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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: 12, Authorised, Last updated: 29/08/2023
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Human medicine European public assessment report (EPAR): Rinvoq (updated)

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , , Revision: 17, Authorised, Last updated: 29/08/2023
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Human medicine European public assessment report (EPAR): Lupkynis (updated)

Voclosporin, Lupus Nephritis
Date of authorisation: 15/09/2022, , Revision: 2, Authorised, Last updated: 29/08/2023
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Human medicine European public assessment report (EPAR): Gavreto (updated)

pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021, , , Revision: 6, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Enjaymo (updated)

sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022, , , Revision: 3, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Reblozyl (updated)

Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020, , , Revision: 5, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Cerdelga (updated)

eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015, , , 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
List item

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
List item

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
List item

Human medicine European public assessment report (EPAR): Tolucombi

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

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