3113 results
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Human medicine European public assessment report (EPAR): Tibsovo (updated)
Ivosidenib, Leukemia, Myeloid, Acute; Cholangiocarcinoma
Date of authorisation: 04/05/2023,
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, Authorised, Last updated: 12/05/2023
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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: 5, Authorised, Last updated: 03/05/2023
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 5, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , 
, Revision: 4, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 6, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , , Revision: 9, Authorised, Last updated: 04/04/2023
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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 (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , , Revision: 4, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Trecondi
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019, Revision: 3, Authorised, Last updated: 25/01/2023 -
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 11, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Waylivra
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,, , , Revision: 6, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Oxlumo
Lumasiran sodium, Hyperoxaluria, Primary
Date of authorisation: 19/11/2020,, , Revision: 3, Authorised, Last updated: 13/10/2022
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Human medicine European public assessment report (EPAR): Poteligeo
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, , Revision: 5, Authorised, Last updated: 28/04/2022
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Summary of opinion: Tidhesco
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Trecondi
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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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