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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter Withdrawn applications Remove Withdrawn applications filter

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

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , Revision: 9, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Praxbind (updated)

idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015, , Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Takhzyro

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , , Revision: 10, Authorised, Last updated: 13/12/2022
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Human medicine European public assessment report (EPAR): Jorveza

budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018, , , Revision: 6, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Zytiga

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011, , Revision: 26, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Cabometyx

cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016, , Revision: 15, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Zynteglo

Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019, , , , , Revision: 5, Withdrawn, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Tagrisso

osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016, , Revision: 17, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Soliris

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007, , , Revision: 33, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Harvoni

ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014, , Revision: 26, Authorised, Last updated: 10/11/2022
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Human medicine European public assessment report (EPAR): Tegsedi

inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018, , , , Revision: 12, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Kalydeco

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , Revision: 34, Authorised, Last updated: 21/10/2022
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Human medicine European public assessment report (EPAR): Iclusig

ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013, , , Revision: 24, Authorised, Last updated: 21/10/2022
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Human medicine European public assessment report (EPAR): Vpriv

velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010, , Revision: 19, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Isentress

Raltegravir, HIV Infections
Date of authorisation: 19/12/2007, , Revision: 42, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Bylvay

Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021, , , , Revision: 2, Authorised, Last updated: 05/10/2022
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Human medicine European public assessment report (EPAR): Hemlibra

Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018, , , Revision: 12, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Maviret

glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, , Revision: 17, Authorised, Last updated: 23/08/2022
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Human medicine European public assessment report (EPAR): Sovaldi

Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, , Revision: 26, Authorised, Last updated: 22/08/2022
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Human medicine European public assessment report (EPAR): Brineura

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Exviera

dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , Revision: 25, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Darzalex

Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016, , , Revision: 19, Authorised, Last updated: 11/07/2022
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 18, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Kanuma

sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015, , , , Revision: 8, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Kisplyx

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , Revision: 17, Authorised, Last updated: 17/06/2022