News from the Danish Medicines Agency
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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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Second contract ensures access to a potential vaccine for COVID-19
| 25 September 2020 |
A month ago, an agreement was entered with AstraZeneca on the supply of vaccines for 2.4 million citizens in Denmark if the vaccine is approved. Now the European Commission, on behalf of the EU member states, has negotiated a second contract, potentially giving Denmark the opportunity to buy some 3.7 million vaccine doses. More contracts are on the way.
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Denmark and EU part of an international vaccine alliance to ensure COVID-19 vaccines for low- and middle-income countries
| 25 September 2020 |
Denmark, the other EU countries and the European Commission have come together to support the vaccine alliance COVAX whose aim is to ensure that low- and middle-income countries have access to vaccines.
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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.