2710 results
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Human medicine European public assessment report (EPAR): Hepcludex (updated)
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,
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, Revision: 4, Authorised, Last updated: 24/09/2021
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Human medicine European public assessment report (EPAR): Oxlumo (updated)
Lumasiran sodium, Hyperoxaluria, Primary
Date of authorisation: 19/11/2020,, , Revision: 1, Authorised, Last updated: 13/09/2021
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , , Revision: 2, Authorised, Last updated: 30/08/2021
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Human medicine European public assessment report (EPAR): Poteligeo
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, , Revision: 3, Authorised, Last updated: 20/08/2021
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Human medicine European public assessment report (EPAR): Calquence
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Revision: 1, Authorised, Last updated: 02/08/2021
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Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 2, Authorised, Last updated: 28/06/2021
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 1, Authorised, Last updated: 23/06/2021
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Human medicine European public assessment report (EPAR): Waylivra
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,, , , Revision: 3, Authorised, Last updated: 22/06/2021
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 3, Authorised, Last updated: 25/05/2021
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Human medicine European public assessment report (EPAR): Trecondi
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,, Revision: 2, Authorised, Last updated: 07/09/2020
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Human medicine European public assessment report (EPAR): Tecartus
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured, Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , , Authorised, Last updated: 25/01/2021
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Withdrawn application: Radicava
date of withdrawal: 24/05/2019, Initial authorisation, Last updated: 14/08/2019 -
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Withdrawn application: Advexin
date of withdrawal: 17/12/2008, Initial authorisation, Last updated: 19/12/2009 -
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Withdrawn application: Vorinostat MSD
date of withdrawal: 13/02/2009, Initial authorisation, Last updated: 17/02/2009 -
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Withdrawn application: Theraloc
date of withdrawal: 01/12/2008, Initial authorisation, Last updated: 04/12/2008 -
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Withdrawn application: Vekacia
ciclosporin, date of withdrawal: 14/11/2008, Initial authorisation, Last updated: 18/11/2008 -
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Withdrawn application: Lenalidomide Celgene Europe
lenalidomide, date of withdrawal: 30/05/2008, Initial authorisation, Last updated: 04/06/2008 -
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Withdrawn application: orBec
date of withdrawal: 22/05/2008, Initial authorisation, Last updated: 23/05/2008 -
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Withdrawn application: Kiacta
date of withdrawal: 13/03/2008, Initial authorisation, Last updated: 17/03/2008 -
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Withdrawn application: Retisert
date of withdrawal: 16/07/2007, Initial authorisation, Last updated: 23/07/2007 -
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Withdrawn application: Cerepro
date of withdrawal: 13/07/2007, Initial authorisation, Last updated: 20/07/2007 -
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Withdrawn application: Orathecin
date of withdrawal: 19/01/2006, Initial authorisation, Last updated: 23/01/2006 -
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Orphan designation: Single-chain urokinase plasminogen activator for: Treatment of pleural empyema (updated)
Date of designation: 16/12/2014, Positive, Last updated: 27/09/2021 -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease (updated)
Date of designation: 06/06/2010, Positive, Last updated: 24/09/2021 -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease (updated)
Date of designation: 06/06/2010, Positive, Last updated: 24/09/2021