News of considerable importance to patient safety

  • New regulations on Stockpiling of Critical Medicines effective on July 1 2024

    | 01 July 2024 |

    It will soon be mandatory for companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. The affected companies will have six months to prepare for compliance, and, in August, the Danish Medicines Agency is holding information meetings about the new rules.

  • 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.

  • 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.

  • Danish Medicines Agency investigates a case of inflammatory condition reported after COVID-19 vaccination

    | 26 August 2021 |

    In collaboration with the EMA, the Danish Medicines Agency is investigating whether the rare inflammatory condition of MIS-C, previously observed as an aftereffect of COVID-19 infection in children and adolescents, can also occur after vaccination. While no causality with the vaccine has been established, it cannot be excluded either.

  • New campaign aimed at doctors: High-quality ADR reports make a difference

    | 09 July 2021 |

    The monitoring of the safety of COVID-19 vaccines over the last months has shown us just how important the reports on suspected side effects from doctors are. A new campaign to promote the quality of ADR reports submitted by doctors sets out to improve the monitoring of medicine safety even further.

  • New EU rules on medical devices set to strengthen patient safety

    | 26 May 2021 |

    Today new EU rules on medical devices enter into force. The new rules aim to strengthen patient safety and ensure that patients can benefit from new innovative devices. Medical devices cover anything from contact lenses to state-of-the-art surgical equipment.

  • EMA: The AstraZeneca vaccine possibly causes rare, serious symptoms – but remains authorised for use

    | 08 April 2021 |

    An expert committee formed by the EMA has now concluded that it is possible that the rare cases of blood clots combined with low levels of platelets and bleeding are caused by the AstraZeneca COVID-19 vaccine. It is maintained, however, that the benefits of using the vaccine still outweigh any possible risks.

  • COVID-19 Vaccine AstraZeneca: Investigations of blood clots with low numbers of platelets and bleeding continue in Denmark and in the EU

    | 26 March 2021 |

    The EMA is convening an expert group on 29 March to provide input to the continued investigation of blood clot cases, including the very rare cases of blood clots accompanied by low numbers of platelets in people vaccinated with COVID-19 Vaccine AstraZeneca.

  • Status on the drug regulatory authorities’ investigation of blood clots after vaccination with the AstraZeneca vaccine

    | 18 March 2021 |

    The European Medicines Agency, EMA, and the drug regulatory authorities in Europe have reviewed reports of the rare and unusual symptoms of low levels of blood platelets, blood clots and bleeding after vaccination with the AstraZeneca’s COVID-19 vaccine. The conclusion is that the AstraZeneca vaccine is generally a safe and efficient vaccine, but that it cannot be ruled out that these symptoms may be caused by the AstraZeneca vaccine.

  • Danish Medicines Agency sends out updated letter to people who have received the AstraZeneca vaccine within the last 14 days

    | 15 March 2021 |

    Today, the Danish Medicines Agency has sent out an updated letter to people who have received the AstraZeneca vaccine within the last 14 days. The purpose is to increase awareness on the symptoms that people should react to.

  • Drug regulatory authorities are investigating reports of blood clots after AstraZeneca vaccinations

    | 11 March 2021 |

    The Danish Medicines Agency together with the EMA and the other drug regulatory authorities in Europe have launched an investigation of the AstraZeneca vaccine after reports of blood clots in people given the vaccine. One report concerns the death of a person in Denmark. At present, there is no evidence to conclude that there is an association between the vaccine and the blood clots.

  • Opioid use in Denmark is decreasing

    | 04 November 2020 |

    Total sales of opioids have decreased by more than 20 per cent in the past four years, and there are now fewer Danes who use the most common type of opioid, tramadol. So reveals two new studies from the Danish Health Data Authority and the Danish Medicines Agency.

  • Clinical trials of hydroxychloroquine are stopped temporarily

    | 27 May 2020 |

    Five clinical trials in Denmark testing the efficacy of hydroxychloroquine on COVID-19 are discontinued until further notice. This takes place after a major international study has indicated that there is no beneficial effect of using the product; in contrast, there could be serious adverse reactions.

  • EMA clarifies use of chloroquine and hydroxychloroquine for COVID-19

    | 02 April 2020 |

    Chloroquine and hydroxychloroquine must only be used for COVID-19 in clinical trials or national emergency use programmes in COVID-19 patients whose condition is critical, says the European Medicines Agency, EMA.

  • Risk of supply failure: Use protective equipment rationally

    | 22 March 2020 |

    There is a risk that the healthcare sector will run out of protective equipment, such as hand sanitizer, facemasks and visors/shields, which are crucial in the fight against coronavirus. We urge everyone to use at little as possible without compromising on safety.

  • Restriction on sale of medicines in pharmacies (clarification)

    | 19 March 2020 |

    The Minister of Health has activated parts of the drug preparedness. This means that you cannot buy more prescription medicines at the pharmacy than what you normally use, and that the amount of OTC medicines being dispensed has been limited. The decision has been taken to avoid hoarding.

  • Withdrawal of vaginal mesh

    | 03 May 2019 |

    Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient. As a result, the products will no longer be available in Denmark.

  • Vaginal mesh from Bard removed from the EU markets

    | 12 March 2019 |

    The company Bard has decided to stop the sale of vaginal mesh implants on the markets in the EU. The decision is based on commercial reasons according to Bard.

  • DKMA Update December 2018

    | 23 January 2019 |

    In this issue of DKMA Update you can read about safety for medical devices; new biosimilar medicines for Humira; better conditions for clinical trials in Denmark; new front page for our website and much more