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New data analysis: Ibuprofen does not worsen COVID-19 infection
| 09 September 2020 |
The use of ibuprofen and other pain-relieving and anti-inflammatory drugs, the so-called NSAIDs, is not associated with mortality or worsening of symptoms in patients infected with coronavirus contrary to the concerns reported by some media and social media back in March.
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Emergency stocks of medicines to prevent supply problems during COVID-19
| 02 September 2020 |
To avoid supply shortages of vital medicines caused by COVID-19, the Danish Medicines Agency has from the outset of the pandemic collaborated with national pharmaceutical wholesalers and Amgros, the organisation responsible for ensuring the supply of medicines to public hospitals in Denmark.
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COVID-19 drug preparedness rules extended for the rest of the year
| 02 September 2020 |
The Minister of Health has decided to extend the applicability of the executive order that lays down special rules for the drug preparedness in connection with the handling of COVID-19 to 31 December 2020.
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Relaxation: Information on face masks permitted to be in Swedish, Norwegian or English besides Danish
| 19 August 2020 |
The Danish Medicines Agency temporarily eases the requirement that the instructions for use and labelling of surgical face masks must be in Danish. This permits the sale of face masks with labelling and instructions for use in Swedish, Norwegian or English until 1 December.
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European strategy for regulation of medicines open for public consultation
| 14 August 2020 |
Availability and the supply of medicines, digital transformation and efforts against antimicrobial resistance are but some of the priority areas in the draft network strategy to 2025 that has been submitted for public consultation by the medicines agencies in Europe and the European Medicines Agency, EMA. The strategy is open for public consultation until 4 September 2020.
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Paracetamol for children may again be sold by retail outlets
| 13 July 2020 |
Paracetamol painkillers for children may again be sold by supermarkets, kiosks and other shops with permission to sell over-the-counter medicines. From March to today, the medicine was only available from pharmacies.
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EU countries join forces to ensure people have access to a COVID-19 vaccine
| 02 July 2020 |
Last week, the EU countries and the European Commission published a European strategy to ensure citizens have swift access to a safe and effective COVID-19 vaccine. The Danish Medicines Agency participates as representative of Denmark in a European steering board that will be coordinating the joint procurement of vaccines.
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EMA recommends approval of remdesivir for COVID-19 in the EU
| 26 June 2020 |
The European Medicines Agency has recommended granting a conditional marketing authorisation to Veklury, a remdesivir-containing product, for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. This will make Veklury the first medicine for COVID-19 that is authorised in the EU.
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Danish Medicines Agency increases communication on medicine supply
| 24 June 2020 |
The Danish Medicines Agency reinforces the communication about the supply of medicines in Denmark through announcements that will be sent out when supply problems are expected to have therapeutic consequences for the patients.
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Suspension paracetamol for children no longer prescription-only
| 15 June 2020 |
The Danish Medicines Agency has now lifted part of its restriction on the sale of suspension paracetamol for children, implying that the medicine can once again be bought over the counter from a pharmacy.
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COVID-19: Regulatory guidance in connection with COVID-19 and possible impact on assessment times
| 04 June 2020 |
The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) – a network for the national drug regulatory authorities in the EU/EEA – have prepared common regulatory guidance for marketing authorisation holders. The guidance can be used during the COVID-19 pandemic and describes situations in which the authorities will apply flexibilities during the pandemic. (updated)
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Becoming part of Europe’s best in class
| 03 June 2020 |
The foundation of the Data Analytics Center was established, our European position was strengthened, yet not all objectives were achieved. This is the conclusion in the Danish Medicines Agency’s annual report for 2019.
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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.
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Several actions taken to ensure the supply of medicine during COVID-19
| 27 May 2020 |
Several actions have been taken nationally to counter supply problems affecting vital medicines during the COVID-19 pandemic. Work is also done at the EU level to ensure the supply of medicines.
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The Danish Medicines Agency will be closed on 22 May 2020
| 18 May 2020 |
The Danish Medicines Agency will be closed on 22 May 2020, the day after Ascension Day. However, we process urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines manufactured by pharmaceutical companies).
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Compassionate use permit for Remdesivir
| 05 May 2020 |
The Danish Medicines Agency would like to inform you that it is possible to apply for a general compassionate use permit for Remdesivir for the treatment of COVID-19 patients who cannot be included in one of the protocol-based clinical trials that are currently being conducted in Denmark.
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COVID-19: Facts about chloroquine and hydroxychloroquine
| 07 April 2020 |
There are many rumours that hydroxychloroquine or chloroquine has a documented effect on COVID-19 and that other countries have approved it for COVID-19.
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COVID-19: See the list of approved Danish clinical trials of medicines for COVID-19
| 07 April 2020 |
The Danish Medicines Agency has approved the first applications for clinical trials of medicines for COVID-19. A list on the Danish Medicines Agency’s website keeps you updated on approved applications.
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Danish Medicines Agency has assessed and sent out replies for an exceptionally high number of clinical trial applications in March
| 06 April 2020 |
The Danish Medicines Agency has been extremely busy lately with the assessment of applications for clinical trials – not only COVID-19-related applications, but also applications for clinical trials of other medicines. All applications have been assessed, and all applicants have received a timely reply.
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Follow worldwide studies and research on medicines for COVID-19
| 03 April 2020 |
The Danish Medicines Agency has formed a COVID-19 group that will continuously update a public list of worldwide studies and research on medicines for COVID-19.
