News from the Danish Medicines Agency
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.
Operation PANGEA 2022: 500 packages seized in the customs and 35 websites reported to the police for illegal trading in pharmaceuticals
| 28 July 2022 |
The last days of June saw the roll out of the 2022 version of the Interpol-managed Operation Pangea XV – a global initiative targeted illegal trade with medicines and medical devices. The Danish Medic
New executive order raises fees in the area of the Danish Medicines Agency
| 03 May 2022 |
Higher fees become payable for medicinal products and pharmaceutical companies as a result of a new executive order entering into force on 1 May 2022. The last time the fees were adjusted was in 2017.
Danish Medicines Agency presents new strategy
| 05 April 2022 |
Lars Bo Nielsen, Director General of the Danish Medicines Agency, announces new 2022-26 strategy for the agency. The strategy supports the Danish Ministry of Health’s joint corporate strategy and emphasises a vision to lead national and international collaboration, for example regarding better use of data and new technology and dialogue with public and society in general.
Danish Medicines Agency closed over Christmas and New Year
| 15 December 2021 |
The Danish Medicines Agency will be closed over Christmas and New Year, from Friday 24 December 2021 to Sunday 2 January 2022, both days included. Read which deadlines apply to applications within the Danish Medicines Agency's area in 2021.
EMA is evaluating Moderna’s COVID-19 vaccine for children aged 6 to 11
| 12 November 2021 |
Moderna has submitted an application to the European Medicines Agency, EMA, to extend its conditional authorisation for its COVID-19 vaccine, Spikewax, to children aged 6 to 11.
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.
Nine million packages of illegally sold medicines and medical devices seized in Operation Pangea
| 09 June 2021 |
This year’s global Interpol action Operation Pangea focused particularly on the illegal sale of medicines and medical devices related to COVID-19. In Denmark, the Danish Medicines Agency identified and reported 46 websites engaged in illicit sale of medicines and medical devices.
Members for the Medicinal Products Committee
| 02 June 2021 |
The Danish Medicines Agency invites interested parties to nominate members to the Medicinal Products Committee for the term of 1 October 2021 to 30 September 2025. Anyone can nominate members to the Medicinal Products Committee, and self-nomination is also possible.
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.
Dean of Aarhus University to join the Danish Medicines Agency as new Director General
| 26 May 2021 |
The Ministry of Health has appointed Lars Bo Nielsen, Dean at Aarhus University, as Director General of the Danish Medicines Agency. Lars Bo Nielsen is a qualified doctor and has extensive leadership experience within both the health and science areas.
Annual report of the Danish Medicines Agency: The COVID-19 pandemic had a considerable impact on our work in 2020.
| 26 April 2021 |
The year 2020 was a year like no other at the Danish Medicines Agency. Both internally and externally, the handling of COVID-19 had a decisive impact on much of our work. However, we managed to retain our European position and to carry through an important reinforcement of our IT landscape, so concludes the Danish Medicines Agency’s annual report for 2020.
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.
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.