19130 results
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Withdrawn application: Sitoiganap
autologous glioma tumor cell lysates (inactivated), allogeneic glioma tumor cell lysates (inactivated), allogeneic glioma tumor cells (inactivated), autologous glioma tumor cells (inactivated), date of withdrawal: 02/05/2022, Initial authorisation, Last updated: 17/06/2022Sitoiganap: Withdrawn application … tumor cells (inactivated) Overview Epitopoietic Research Corporation-Belgium … Corporation-Belgium (E.R.C.) withdrew its application for a The approval to market … -
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Withdrawn application: Aliqopa
copanlisib, date of withdrawal: 20/12/2021, Initial authorisation, Last updated: 10/02/2023Aliqopa: Withdrawn application … copanlisib Overview Bayer AG withdrew its application for a The approval to market … The company withdrew the application on 20 December 2021. What … -
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Withdrawn application: Garsun
artesunate, date of withdrawal: 08/12/2022, Initial authorisation, Last updated: 01/03/2023Garsun: Withdrawn application … B & O Pharm withdrew its application for a The approval to market … The company withdrew the application on 8 December 2022. Expand … -
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Withdrawn application: Imbarkyd
bardoxolone methyl, date of withdrawal: 09/11/2022, Initial authorisation, Last updated: 07/02/2023Imbarkyd: Withdrawn application … bardoxolone methyl Overview Reata Ireland Limited withdrew … Ireland Limited withdrew its application for a The approval to market … -
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Withdrawn application: Kepnetic
date of withdrawal: 10/11/2016, Initial authorisation, Last updated: 16/12/2016Kepnetic: Withdrawn application … Overview On 10 November 2016, Ultragenyx … it wishes to withdraw its application for a The approval to market … -
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Withdrawn application: Hervelous
trastuzumab, date of withdrawal: 14/09/2022, Initial authorisation, Last updated: 13/12/2022Hervelous: Withdrawn application … trastuzumab Overview Prestige Biopharma Belgium … Belgium BVBA withdrew its application for a The approval to market … -
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Withdrawn application: Tuznue
trastuzumab, date of withdrawal: 14/09/2022, Initial authorisation, Last updated: 13/12/2022Tuznue: Withdrawn application … trastuzumab Overview Prestige Biopharma Belgium … Belgium BVBA withdrew its application for a The approval to market … -
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Withdrawn application: HemAryo
eptacog alfa (activated), date of withdrawal: 06/05/2022, Initial authorisation, Last updated: 27/09/2022HemAryo: Withdrawn application … eptacog alfa (activated) Overview UGA Biopharma withdrew its application for a The approval to market … The company withdrew the application on 6 May 2022. What is HemAryo … -
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Withdrawn application: Flynpovi
eflornithine, sulindac, date of withdrawal: 12/10/2021, Initial authorisation, Last updated: 07/12/2021Flynpovi: Withdrawn application … eflornithine sulindac Overview Cancer Prevention Pharma … Ireland) Limited withdrew its application for a The approval to market … -
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Withdrawn application: Lumevoq
lenadogene nolparvovec, date of withdrawal: 20/04/2023, Initial authorisation, Last updated: 26/04/2023Lumevoq: Withdrawn application … lenadogene nolparvovec Overview Gensight Biologics SA withdrew … Biologics SA withdrew its application for a The approval to market … -
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Withdrawn application: Tidhesco (new)
ivosidenib, date of withdrawal: 23/02/2023, Initial authorisation, Last updated: 30/05/2023Tidhesco: Withdrawn application … ivosidenib Overview Key facts Name Tidhesco Product … 23/02/2023 Company making the application Les Laboratoires Servier … -
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Withdrawn application: Raltegravir Viatris
raltegravir potassium, date of withdrawal: 22/02/2023, Initial authorisation, Last updated: 21/04/2023Raltegravir Viatris: Withdrawn application … raltegravir potassium Overview The company Viatris withdrew … company Viatris withdrew its application for a The approval to market … -
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Withdrawn application: Abylqis
arachis hypogaea extract, date of withdrawal: 17/12/2021, Initial authorisation, Last updated: 23/11/2022Abylqis: Withdrawn application … arachis hypogaea extract Overview DBV Technologies withdrew … Technologies withdrew its application for a The approval to market … -
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Withdrawn application: Ilaris
canakinumab, date of withdrawal: 26/10/2022, Post-authorisation, Last updated: 23/02/2023Ilaris: Withdrawn application … canakinumab Overview Novartis withdrew its application for the use of Ilaris in … The company withdrew the application on 26 October 2022. What … -
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Withdrawn application: Miplyffa
arimoclomol, date of withdrawal: 22/03/2022, Initial authorisation, Last updated: 08/02/2023Miplyffa : Withdrawn application … company present to support its application? The company provided results … including miglustat where applicable). Effectiveness was measured … -
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Withdrawn application: Gavreto
pralsetinib, date of withdrawal: 03/11/2022, Post-authorisation, Last updated: 02/02/2023Gavreto: Withdrawn application … pralsetinib Overview Roche Registration GmbH withdrew … Registration GmbH withdrew its application for the use of Gavreto in … -
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Withdrawn application: Febseltiq
infigratinib, date of withdrawal: 11/10/2022, Initial authorisation, Last updated: 30/01/2023Febseltiq: Withdrawn application … infigratinib Overview Helsinn Birex Pharmaceuticals … Pharmaceuticals Ltd withdrew its application for a The approval to market … -
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Withdrawn application: Zektayos - Hepjuvo
obeticholic acid, date of withdrawal: 09/12/2021, Initial authorisation, Last updated: 08/04/2022Zektayos - Hepjuvo: Withdrawn application … obeticholic acid Overview Intercept Pharma International … International Limited withdrew its application for a The approval to market … -
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Withdrawn application: Exkivity
mobocertinib, date of withdrawal: 20/07/2022, Initial authorisation, Last updated: 24/11/2022Exkivity: Withdrawn application … mobocertinib Overview Takeda Pharma A/S withdrew … Takeda Pharma A/S withdrew its application for a The approval of a medicine … -
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Withdrawn application: Sevsury
surufatinib, date of withdrawal: 01/08/2022, Initial authorisation, Last updated: 16/11/2022Sevsury: Withdrawn application … surufatinib Overview Hutchmed Europe B.V. withdrew … Europe B.V. withdrew its application for a The approval to market … -
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Withdrawn application: Dimherity
dimethyl fumarate, date of withdrawal: 22/02/2022, Initial authorisation, Last updated: 03/11/2022Dimherity: Withdrawn application … dimethyl fumarate Overview Sandoz GmbH withdrew its application for a The approval to market … The company withdrew the application on 22 February 2022. What … -
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Withdrawn application: Aduhelm
aducanumab, date of withdrawal: 20/04/2022, Initial authorisation, Last updated: 01/08/2022Aduhelm: Withdrawn application … aducanumab Overview Biogen Netherlands B.V. withdrew … Netherlands B.V. withdrew its application for a The approval to market … -
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Withdrawn application: Topotecan SUN
topotecan, date of withdrawal: 03/01/2011, Initial authorisation, Last updated: 23/02/2011Topotecan SUN: Withdrawn application … topotecan Overview On 3 January 2011, Sun Pharmaceutical … it wishes to withdraw its application for a marketing authorisation … -
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Withdrawn application: Neffy
epinephrine, date of withdrawal: 04/04/2022, Initial authorisation, Last updated: 20/05/2022Neffy: Withdrawn application … epinephrine Overview ARS Pharmaceuticals IRL … IRL, Limited withdrew its application for a The approval to market … -
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Withdrawn application: Asimtufii (new)
aripiprazole, date of withdrawal: 02/05/2023, Initial authorisation, Last updated: 26/05/2023Asimtufii: Withdrawn application … aripiprazole Overview Otsuka Pharmaceutical Netherlands … Netherlands B.V. withdrew its application for a The approval to market …