• EMA recommends approval of remdesivir for COVID-19 in the EU

    | 26 June 2020 |

    The European Medicines Agency has recommended granting a conditional marketing authorisation to Veklury, a remdesivir-containing product, for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. This will make Veklury the first medicine for COVID-19 that is authorised in the EU.

  • Danish Medicines Agency increases communication on medicine supply

    | 24 June 2020 |

    The Danish Medicines Agency reinforces the communication about the supply of medicines in Denmark through announcements that will be sent out when supply problems are expected to have therapeutic consequences for the patients.

  • Suspension paracetamol for children no longer prescription-only

    | 15 June 2020 |

    The Danish Medicines Agency has now lifted part of its restriction on the sale of suspension paracetamol for children, implying that the medicine can once again be bought over the counter from a pharmacy.

  • COVID-19: Regulatory guidance in connection with COVID-19 and possible impact on assessment times

    | 04 June 2020 |

    The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) – a network for the national drug regulatory authorities in the EU/EEA – have prepared common regulatory guidance for marketing authorisation holders. The guidance can be used during the COVID-19 pandemic and describes situations in which the authorities will apply flexibilities during the pandemic. (updated)

  • Becoming part of Europe’s best in class

    | 03 June 2020 |

    The foundation of the Data Analytics Center was established, our European position was strengthened, yet not all objectives were achieved. This is the conclusion in the Danish Medicines Agency’s annual report for 2019.