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7 results
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Withdrawn application: Translarna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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Withdrawn application: Omontys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Withdrawn application: Memantine FGK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Withdrawn application: Epostim
epoetin alfa, date of withdrawal: 15/03/2011, Initial authorisation, Last updated: 19/04/2011 -
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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): Polivy (polatuzumab vedotin)
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020