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News from the Danish Medicines Agency

  • Danish Medicines Agency closed over Christmas and New Year

    | 28 November 2023 |

    The Danish Medicines Agency will be closed over Christmas and New Year, from Saturday 23 December 2023 to Monday 1 January 2024, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2023.

  • First electronic product information published for medicines

    | 09 November 2023 |

    Four EU countries – including Denmark – have published the first versions of digital product information for selected medicines. A pilot initiative is right now testing the use of digital product information for medicines used by citizens and healthcare professionals throughout the EU.

  • More reports at the beginning of the vaccination programme, but no suspicion of safety differences between COVID-19 vaccine batches

    | 01 November 2023 |

    A new analysis from the Danish Medicines Agency shows that the number of reports of suspected side effects after vaccination with COVID-19 vaccines is highly related to the time the individual vaccine batches were used.

  • Danish Medicines Agency releases COVID-19 vaccine batch from quarantine

    | 20 October 2023 |

    On 17 October, the Danish Medicines Agency decided to quarantine a specific batch (batch HG2252) of COVID-19 vaccines from Pfizer/BioNTech. Since then, the Danish Medicines Agency and Pfizer have worked together to review the documentation of the batch in question, based on which the agency has now decided to release said batch from quarantine.

  • Covid-19 vaccine batch in quarantine

    | 18 October 2023 |

    As a precautionary measure, the Danish Medicines Agency has decided to quarantine a specific batch of COVID-19 vaccines from Pfizer/BioNTech in response to vaccine centres having observed a possible error when using a specific vaccine batch. Over the next days, some people will therefore experience having their vaccination appointment cancelled. At present, there are no signs of any impact on the efficacy and safety of the batch in question.

  • The Danish Medicines Agency suspends the Danish marketing authorisations of four generic medicines

    | 15 March 2023 |

    The European Commission has reached a decision in the case about the bioequivalence company Synchron Research, deciding that a number of generic medicines must be suspended in the EU counties where they are authorised. The Danish Medicines Agency therefore suspends the marketing authorisations of four medicines.

  • Recall of the antibiotic Dicillin from Sandoz

    | 07 February 2023 |

    Patients who are treated with Dicillin Sandoz 500 mg capsules are instructed to return the medicine to a pharmacy and have it replaced. It is important not to stop treatment but to have the medicine replaced with another antibiotic. The pharmacies have been informed to dispense an alternative medicine.