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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.
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Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
| 11 March 2024 |
Give your valuable feedback to the European Pharmacopoeia (Ph. Eur.) in the field of setting standards for therapeutic mAbs. The survey will take about 20 minutes. Please complete the survey by
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Regulatory training on transitional trials in CTIS with open question and answers session
| 13 February 2024 |
EMA has organized in the series of the CTIS Bitesize Talk an event related to the transitional trial in CTIS Thursday, 29 February 2024, 16:30 (CET) - 18:00 (CET).
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ACT EU Training for non-commercial sponsors. Transitioning trials to the CTR
| 02 February 2024 |
ACT EU training for non-commercial sponsors Friday, 09 February 2024, from 10:00 AM (CET) to 1:00 PM (CET). The event will be live broadcast and no registration is required to follow the live broadcast on EMA’s website.
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Continued control of companies' uploading of leaflets to the Danish Medicines Agency's portal DKMAnet
| 01 February 2024 |
The Danish Medicines Agency’s Department for Control and Security of Supply resumes the work of checking whether readable leaflets have been uploaded to www.indlaegsseddel.dk
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Updating of summaries of product characteristics due to changed ATC codes for 2024
| 02 January 2024 |
Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2024.
