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105 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Onpattro
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,
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, Revision: 9, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 17, Authorised, Last updated: 18/01/2022
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 23, Authorised, Last updated: 14/12/2021
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Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 13/12/2021
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Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, , Revision: 16, Authorised, Last updated: 10/12/2021
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Human medicine European public assessment report (EPAR): Lenvima
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 16, Authorised, Last updated: 01/12/2021
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Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 41, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 24, Authorised, Last updated: 12/10/2021
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, , Revision: 31, Authorised, Last updated: 09/09/2021
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Human medicine European public assessment report (EPAR): Praxbind
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 10, Authorised, Last updated: 06/07/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/06/2021
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, , Revision: 11, Authorised, Last updated: 12/05/2021
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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: 7, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , 
, Revision: 5, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Prepandrix
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 14/05/2008,, Revision: 13, Withdrawn, Last updated: 23/02/2021
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Human medicine European public assessment report (EPAR): Lartruvo
Olaratumab, Sarcoma
Date of authorisation: 09/11/2016,, , 
, Revision: 3, Withdrawn, Last updated: 02/09/2019
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Human medicine European public assessment report (EPAR): Daklinza
daclatasvir dihydrochloride, Hepatitis C, Chronic
Date of authorisation: 22/08/2014,, Revision: 15, Withdrawn, Last updated: 30/08/2019
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Orphan designation: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide (ivacaftor) for: Treatment of cystic fibrosis
Date of designation: 08/07/2008, Positive, Last updated: 25/01/2022 -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease
Date of designation: 06/06/2010, Positive, Last updated: 24/09/2021 -
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Orphan designation: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab) for: Treatment of hereditary angioedema
Date of designation: 09/10/2015, Positive, Last updated: 20/09/2021 -
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Orphan designation: Chimeric anti-interleukin-6 monoclonal antibody (siltuximab) for: Treatment of Castleman's disease
Date of designation: 30/11/2007, Positive, Last updated: 26/08/2021 -
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Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 17/07/2012, Positive, Last updated: 28/07/2021 -
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Orphan designation: Risdiplam for: Treatment of spinal muscular atrophy
Date of designation: 26/02/2019, Positive, Last updated: 04/05/2021 -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of designation: 23/04/2012, Positive, Last updated: 22/09/2020 -
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Orphan designation: Recombinant human lysosomal acid lipase for: Treatment of lysosomal acid lipase deficiency
Date of designation: 17/12/2010, Positive, Last updated: 20/11/2019