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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine type Accelerated assessment Remove Accelerated assessment filter

Medicine Orphan designations Remove Orphan designations filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) 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Date of authorisation: 29/05/2019, , , , , Revision: 5, Withdrawn, Last updated: 30/11/2022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