DEC: vaginal ketoconazole risk management plan identifies hypersensitivity as an important risk

The DEC website hosts a summary of the risk management plan for Dermazol, a ketoconazole vaginal suppository. According to the abstract attached to the source, the document describes important safety risks and measures to minimise them. Hypersensitivity reactions are classified as important identified risks. The available abstract does not report their frequency, severity or clinical manifestations.

No important potential risks or missing safety information are listed in the description of the plan. Routine risk minimisation activities and ongoing pharmacovigilance are provided for to support safe use. The available abstract does not detail the specific measures or their content. The safety information is consistent with that of the reference medicinal product.

No post-authorisation studies are mandated, and the applicant does not plan any such studies. For clinical practice, the document focuses on considering hypersensitivity reactions and following the specified routine risk minimisation measures. The available description does not report new restrictions on use or changes to the product information.