Notifications about medicines to healthcare professionals
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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.
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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.
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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.
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Drug regulatory authorities are investigating reports of blood clots after AstraZeneca vaccinations
| 11 March 2021 |
The Danish Medicines Agency together with the EMA and the other drug regulatory authorities in Europe have launched an investigation of the AstraZeneca vaccine after reports of blood clots in people given the vaccine. One report concerns the death of a person in Denmark. At present, there is no evidence to conclude that there is an association between the vaccine and the blood clots.
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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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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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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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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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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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Henstilling om, hvordan præparatet remdesivir skal bruges til behandling af COVID-19 i såkaldt compassionate use-programs i EU
Under et ekstraordinært møde, der blev afholdt den 2. april 2020, gav det europæiske medicinalagentur EMA's humane lægemiddeludvalg (CHMP) henstillinger om, hvordan præparatet remdesivir skal bruges til behandling af COVID-19 i såkaldt compassionate use-programs i EU, dvs. via udleveringstilladelser.