News
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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.
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EMA clarifies use of chloroquine and hydroxychloroquine for COVID-19
| 02 April 2020 |
Chloroquine and hydroxychloroquine must only be used for COVID-19 in clinical trials or national emergency use programmes in COVID-19 patients whose condition is critical, says the European Medicines Agency, EMA.
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Clarification on companies’ notification of supply problems to the Danish Medicines Agency
| 01 April 2020 |
The Danish Medicines Agency would like to clarify when and how companies must notify the Danish Medicines Agency of any supply problems they might experience.
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No evidence confirms reports that blood pressure medicines could worsen COVID-19
| 30 March 2020 |
After several specialist media and patient organisations in Denmark have disproved reports that ACE inhibitors and angiotensin receptor blockers could worsen the condition of COVID-19 patients, the European Medicines Agency now sends the same message.
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Danish Medicines Agency initiates COVID-19 data analyses
| 27 March 2020 |
What is the drug consumption and medical history of Danish COVID-19 patients? And does the use of certain painkillers, including ibuprofen, affect the disease course of COVID-19?
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Inquiries to the Danish Medicines Agency about medicines
| 27 March 2020 |
It is important to us that companies and industry associations feel they receive a prompt reply when they contact the Danish Medicines Agency.
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More than 1,000 have responded to the Denmark helps Denmark campaign
| 27 March 2020 |
This weekend the Danish Medicines Agency launched the Denmark helps Denmark campaign wherein companies and manufacturers can make contributions to increase the supply of protective equipment like facemasks, gloves and shields for frontline staff. Thursday the number of responses exceeded 1,000.