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Direct Healthcare Professional Communication (DHPC) on topiramate: New restrictions to prevent exposure during pregnancy
2023.11.02
Active substance: topiramate
This letter is sent in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices to inform you of the implementation of a pregnancy prevention programme for topiramate-containing medicinal products. Topiramate can cause major congenital malformations and foetal growth restriction when used during pregnancy. New contraindications apply for the treatment of epilepsy. Educational materials will be put in place.
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN