• Data requirements in place in the EU for second-generation COVID-19 vaccines

    | 26 February 2021 |

    With continued mutations of SARS-CoV-2, the current COVID-19 vaccines may need to be adapted to ensure their efficacy. To ensure that second-generation vaccines can be made available as fast as possible, the European Medicines Agency has just issued guidance for manufacturers.

  • Announcement of altered dispensing status for gadolinium-containing contrast agents (ATC code: V08CA)

    | 22 February 2021 |

    The Danish Medicines Agency hereby informs you that the dispensing status for all gadolinium-containing contrast agents, regardless of strength, pack size and indication is changed to ‘BEGR’ (only to be dispensed to hospitals) as of 5 October 2020.

  • Danish Medicines Agency expands capacity for safety monitoring of COVID-19 vaccines

    | 10 February 2021 |

    The Danish Medicines Agency and drug regulatory authorities around the world find themselves in a massive historic task of monitoring the safety of COVID-19 vaccines. Thousands of people have already been vaccinated in Denmark, and within a short period of time, the rest of the Danish population is expected to be offered vaccination against COVID-19. To ensure intensive and close monitoring of the COVID-19 vaccines, the Danish Medicines Agency is stepping up its capacity by recruiting more employees to process reports of suspected side effects.