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     519  0 Kommentare Novo Nordisk submits application in the EU for including data from the DEVOTE trial in the Tresiba® label

    Bagsværd, Denmark, 14 June 2017 - Novo Nordisk today announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for including data in the label for Tresiba® (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba® compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.

    Further information

    Media:    
    Katrine Sperling +45 4442 6718 krsp@novonordisk.com
    Ken Inchausti (US) +1 609 786 8316 kiau@novonordisk.com
         
    Investors:    
    Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
    Hanna Ögren +45 3079 8519 haoe@novonordisk.com
    Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
    Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com

    Company announcement No 44/2017





    This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
    The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
    Source: Novo Nordisk A/S via Globenewswire




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    Novo Nordisk submits application in the EU for including data from the DEVOTE trial in the Tresiba® label Bagsværd, Denmark, 14 June 2017 - Novo Nordisk today announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for including data in the label for Tresiba® (insulin degludec) from the DEVOTE trial, a …

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