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83 results
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Withdrawn application: Retisert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Withdrawn application: Blectifor
caffeine citrate, date of withdrawal: 09/03/2017, Initial authorisation, Last updated: 16/05/2017 -
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Withdrawn application: orBec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Withdrawn application: Cerepro
date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 01/02/2011 -
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Withdrawn application: Folcepri
date of withdrawal: 16/05/2014, Initial authorisation, Last updated: 14/08/2014 -
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Withdrawn application: Vynpenta (previously AvacopanChemoCentryx)
date of withdrawal: 23/01/2019, Initial authorisation, Last updated: 15/05/2020 -
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Withdrawn application: Epjevy
date of withdrawal: 07/02/2019, Initial authorisation, Last updated: 01/03/2019 -
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Withdrawn application: Radicava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Withdrawn application: Xyndari
date of withdrawal: 18/09/2019, Initial authorisation, Last updated: 11/02/2020 -
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Withdrawn application: Upkanz
deferiprone, date of withdrawal: 10/08/2020, Initial authorisation, Last updated: 28/10/2020 -
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Withdrawn application: Puldysa
idebenone, date of withdrawal: 28/10/2020, Initial authorisation, Last updated: 18/01/2021 -
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Withdrawn application: Roctavian
Valoctocogene roxaparvovec, date of withdrawal: 04/11/2020, Initial authorisation, Last updated: 13/11/2020 -
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Withdrawn application: Tibsovo
ivosidenib, date of withdrawal: 13/10/2020, Initial authorisation, Last updated: 16/04/2021 -
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Withdrawn application: Zydelig
idelalisib, date of withdrawal: 30/01/2018, Post-authorisation, Last updated: 23/02/2018 -
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Withdrawn application: Aliqopa
copanlisib, date of withdrawal: 20/12/2021, Initial authorisation, Last updated: 28/01/2022 -
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Direct healthcare professional communication (DHPC): Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
Active substance: Lomitapide, DHPC type: Post-authorisation measure, Last updated: 17/02/2021 -
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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: Glivec
imatinib, date of withdrawal: 18/10/2006, Post-authorisation, Last updated: 23/10/2006 -
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Withdrawn application: Flynpovi
eflornithine, sulindac, date of withdrawal: 12/10/2021, Initial authorisation, Last updated: 07/12/2021 -
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Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)
Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022 -
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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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Withdrawn application: Evoltra
clofarabine, date of withdrawal: 18/03/2008, Post-authorisation, Last updated: 19/03/2008 -
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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate): Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020 -
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Direct healthcare professional communication (DHPC): Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis
Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, DHPC type: Adverse event, Last updated: 22/03/2021