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69 results
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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,,
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, 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,,
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, Revision: 5, Withdrawn, Last updated: 30/11/2022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,,
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, 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,,
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, 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,,
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, 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,,
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, 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