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Notes
PRAC = Pharmacovigilance Risk Assessment Committee
including vision changes, hearing loss or ringing in the ears, loss of smell, headaches, memory loss, seizures or weakness in arms and legs.
This restriction is already in place for higher dose cyproterone-containing medicines.
Reference
European Medicines Agency. Restrictions in use of cyproterone due to meningioma risk. Internet Document : 14 Feb 2020. Available from: URL: https://www.ema.europa.eu/en/news/restrictions-use-cyproterone-due-meningioma-risk
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PRAC recommends cyproterone restrictions due to meningioma risk. Reactions Weekly 1793, 5 (2020). https://doi.org/10.1007/s40278-020-75347-0
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DOI: https://doi.org/10.1007/s40278-020-75347-0