News from the Danish Medicines Agency

  • 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.

  • 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.

  • Home-based clinical trials will be possible in the future

    | 20 January 2021 |

    Participate in a clinical trial from the comfort of your own home. It may sound a little crazy, but it is actually possible in many respects. The Danish Medicines Agency has started a project to enable researchers and pharmaceutical companies to conduct so-called decentralised clinical trials which by means of new technologies make it easier for people to participate in clinical trials. It makes it more convenient for the participants and increases efficiency, while ultimately getting medicines to market faster for the benefit of patients.

  • EMA’s expert committee meets 6 January to decide on Moderna’s COVID-19 vaccine

    | 22 December 2020 |

    The expert committee of the European Medicines Agency, EMA, which is presently assessing Moderna’s application for conditional marketing authorisation of their COVID-19 vaccine in the EU has scheduled a meeting on 6 January at which it may recommend authorisation to the European Commission. If so, the European Commission may formally authorise the vaccine within a few days.

  • EMA starts rolling review of corona vaccine from Janssen

    | 02 December 2020 |

    The European Medicines Agency, EMA, has started a rolling review of data from the clinical trials of a potential COVID-19 vaccine from the manufacturer Janssen. The EMA has previously started the same process for other potential vaccines from AstraZeneca, BioNTech/Pfizer and Moderna.

  • EMA receives the first applications for conditional marketing authorisation of COVID-19 vaccines

    | 02 December 2020 |

    The EMA has received the first two applications from companies for conditional marketing authorisation of COVID-19 vaccines. The authorisations could be granted in only a few weeks’ time if the agency’s independent pharmaceutical experts assess the documentation on efficacy and safety to be sufficient.

  • Remdesivir for treatment of COVID-19 to continue in Denmark and Europe until further notice

    | 24 November 2020 |

    Remdesivir for the treatment of hospitalised COVID-19 patients will continue in Denmark and the rest of Europe, awaiting the collection of further data that will provide conclusive evidence on the medicine’s efficacy and safety.

  • Fourth contract ensuring access to a potential COVID-19 vaccine

    | 19 November 2020 |

    Denmark has entered into a fourth contract with a vaccine manufacturer that will ensure the delivery of vaccines for COVID-19; the contract is signed by the European Commission on behalf of the EU member states. The contract means that about 2 million people can be vaccinated against coronavirus, provided the vaccine is approved by the authorities.

  • EMA starts rolling review of corona vaccine from Moderna

    | 17 November 2020 |

    The European Medicines Agency, EMA, has started a rolling review of data from the clinical trials of a potential COVID-19 vaccine from the manufacturer Moderna. The EMA has previously started the same process for other potential vaccines from AstraZeneca and BioNTech/Pfizer.

  • Opens today: New Data Analytics Center is to give people better and safer medicines and medical devices

    | 16 November 2020 |

    Today, the Danish Medicines Agency officially opens its new Data Analytics Center (DAC), a center that is to translate information and data about medicines and medical devices into knowledge that will benefit the general public. Objective: Better and safer medicines and medical devices.

  • 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.

  • A rolling review of one more potential COVID-19 vaccine has started

    | 06 October 2020 |

    A rolling review of one more potential COVID-19 vaccine has been started by the European Medicines Agency, EMA. This happens only five days after the EMA started the same process for AstraZeneca’s potential COVID-19 vaccine.

  • EMA: Transparency and scientific independence – the basis for authorising COVID-19 vaccines in the EU

    | 06 October 2020 |

    The European Medicines Agency, EMA, has stated in an announcement that its high standards for transparency and independence will be upheld when its experts assess and potentially authorise COVID-19 medicines and vaccines. “We need to hurry, but we must never rush things through”, said Director General of the Danish Medicines Agency, Thomas Senderovitz.

  • Danish Medicines Agency takes tougher action to ensure the publication of clinical trial results

    | 06 October 2020 |

    A fine or imprisonment of up to four months is the ultimate punishment if the results from clinical trials of medicines are not published. The Danish Medicines Agency will be taking a tougher line on investigators – the so-called sponsors of clinical trials of medicines – if they do not publish the results of the trials they carry out.

  • EMA starts rolling review of a potential COVID-19 vaccine

    | 01 October 2020 |

    The European Medicines Agency, EMA, has started a rolling review of trial data on a potential COVID-19 vaccine. The vaccine is from AstraZeneca with which the European Commission signed a purchase contract about a month ago on behalf of Denmark (among others).

  • Dexamethasone can be used for the treatment of certain COVID-19 patients

    | 25 September 2020 |

    Dexamethasone can be used for the treatment of hospitalised COVID-19 patients requiring supplemental oxygen. This has been confirmed by the European Medicines Agency (EMA) after a review of the results from the so-called RECOVERY study on the use of dexamethasone in the treatment of COVID-19.

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