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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): Hemlibra (updated)

Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018, , Revision: 13, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Empliciti (updated)

Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016, , Revision: 11, Authorised, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Maviret (updated)

glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, , Revision: 21, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Lenvima (updated)

lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015, , , Revision: 17, Authorised, Last updated: 28/02/2023
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Human medicine European public assessment report (EPAR): Onpattro (updated)

patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018, , , , Revision: 10, Authorised, Last updated: 28/02/2023
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Human medicine European public assessment report (EPAR): Sylvant

siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014, , , Revision: 12, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 19, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Harvoni

ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014, , Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Sovaldi

Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014, , Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Evrysdi

Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021, , , Revision: 3, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Coagadex

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

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): 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