News on pharmacovigilance
Here you can read news in the pharmacovigilance area. The section will primarily bring news about updated information on specific medicines/adverse reactions from the PRAC and CHMD committees of the European Medicines Agency (EMA), but we will also be writing news.
The content/news will be selected based on the following criteria:
- New updated information on specific medicines/adverse reactions from the PRAC and/or the CHMP – usually adjusted to Danish settings
- Medicine consumption – medicines with a particularly high consumption among the public
- The severity/frequency of the adverse reaction
- Topicality
- Media coverage
- Medicines requiring attention for whatever reason
- New medicines – medicines marketed within the past two years that are subject to stricter reporting requirements
The news are especially relevant for doctors and healthcare professionals, but could also be relevant for people who work with medicines (whether clinically, in the pharmaceutical industry or in the retail industry) or for anyone else wanting to receive the latest updates on adverse reactions of medicines/safety updates on medicines.
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No evidence that menstrual disorders are triggered by COVID-19 vaccination
| 24 September 2021 |
The Danish Medicines Agency and the European Medicines Agency have reviewed cases of menstrual disorders reported as side effects after COVID-19 vaccination and have found no causal association.
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Status på behandlede indberetninger om formodede bivirkninger ved Vaxzevria (AstraZeneca), uge 36
| 09 September 2021 |
Lægemiddelstyrelsen har behandlet i alt 3.879 indberetninger om formodede bivirkninger ved Vaxzevria (AstraZenecas COVID-19-vaccine). De fleste er kendte og forbigående bivirkninger. Der er behandlet 11 tilfælde af anafylaksi. Tre tilfælde af det usædvanlige sygdomsbillede med lavt antal blodplader, blodpropper samt blødning vurderes at være relateret til vaccinen.