Notifications about medicines to healthcare professionals
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Applications for compassionate use permits on weekdays between Christmas and New Year
| 10 December 2024 |
The Danish Medicines Agency is closed between Christmas and New Year, up to and including 1 January 2025. During this period, we will, however, handle urgent applications for compassionate use permits (applications for dispensing of non-marketed medicines).
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Common nordic packages for better availability
| 02 December 2024 |
Starting from the new year, a pilot project will introduce English-language common nordic packages. This aims to improve the availability by simplifying production and distribution.
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New regulations on Stockpiling of Critical Medicines effective on July 1 2024
| 01 July 2024 |
It will soon be mandatory for companies behind the most critical medicines to maintain stocks to cover initially six weeks’ consumption and to report stocks regularly to the Danish Medicines Agency. The affected companies will have six months to prepare for compliance, and, in August, the Danish Medicines Agency is holding information meetings about the new rules.
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Danish Medicines Agency establishes that chronic urticaria could be a side effect of the Spikevax vaccine
| 05 April 2024 |
The European Pharmacovigilance Risk Assessment Committee (PRAC) has reassessed if chronic urticaria could be a side effect after vaccination with the Spikevax vaccine from Moderna. This follows a review from the Danish Medicines Agency, which has investigated data and reports from patients across the European countries.