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Withdrawn application: Epostim

epoetin alfa, date of withdrawal: 15/03/2011, Initial authorisation, Last updated: 19/04/2011
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Withdrawn application: Evoltra

clofarabine, date of withdrawal: 18/03/2008, Post-authorisation, Last updated: 19/03/2008
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Withdrawn application: Omontys

date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013
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Withdrawn application: Memantine FGK

memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013
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Withdrawn application: Translarna

ataluren, date of withdrawal: 06/03/2017, Post-authorisation, Last updated: 24/03/2017
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa

Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization

Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet

Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)

Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020