Notifications about medicines to healthcare professionals

Applications for compassionate use permits on weekdays between Christmas and New Year

| 15 December 2021 |

The Danish Medicines Agency will be closed over Christmas and New Year, reopening on 3 January 2022. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).

The Danish Medicines Agency's guideline on extraordinary measures for clinical trials due to COVID-19 will not be extended after 01 December 2021

| 04 November 2021 |

We have chosen not to extend the validity of our guidance on extraordinary measures for clinical trials due to COVID-19 further, why the guidance and the granted exemptions expire on 01 December 2021.

Updated guidance on the implementation of decentralised elements in clinical trials with medicinal products

| 10 September 2021 |

You can now read the updated guidance on the implementation of decentralised elements in clinical trials with medicinal products - version 2.0

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.

Guidance on the implementation of decentralised elements in clinical trials with medicinal products is now available

| 04 May 2021 |

Decentralised clinical trials with medicinal products meet the patients, wherever they are, in a faster and more efficient process benefitting both patient, healthcare professionals and industry. It is therefore gratifying to be able to announce that another important milestone has been reached in the Danish Medicines Agency's project to ensure an up-to-date and robust regulatory framework for decentralisation of clinical trials.

EMA: Possible link between the Johnson & Johnson vaccine and unusual symptoms

| 21 April 2021 |

There is a possible link between the Johnson & Johnson vaccine and unusual symptoms with a combination of blood clots in unusual sites, low levels of blood platelets and several cases of bleeding. A few cases have been observed in the USA. The frequency of these unusual symptoms is still being investigated.

EMA to undertake a review of data as to the AstraZeneca vaccine’s efficacy in preventing COVID-19 disease

| 15 April 2021 |

The European Medicines Agency (EMA) is undertaking a review of vaccination data of the COVID-19 vaccine from AstraZeneca. The review will include infection rates, hospitalisations, morbidity and mortality. The EMA will also prepare a recommendation for those who have received the first dose of the vaccine.

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.

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.

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.