News from the Danish Medicines Agency
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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.
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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.
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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.
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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.
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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.
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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.