Regulatory
Published · Updated · 1 min read
DEC: hypersensitivity risk in the risk management plan for ketoconazole and zinc pyrithione shampoo
What it means for practice
Consider hypersensitivity an important identified risk. The plan also identifies missing safety information for use in children, pregnant women and breastfeeding women.
Summary
The description available through the DEC link concerns the risk management plan for Dermazol Plus, a shampoo containing ketoconazole and zinc pyrithione. It describes use for treating and preventing fungal infections of the scalp.
Key safety points
Hypersensitivity reactions are listed among the important identified risks. The plan includes routine risk minimization measures, but the available description does not detail those measures. It provides no frequency, severity or case counts for hypersensitivity reactions.
Missing information and further studies
Missing safety information concerns use in children, pregnant women and breastfeeding women. According to the description, the safety information is consistent with existing data; no additional post-registration studies are planned.
The available description reports no specific DEC decision to change the product information or introduce new restrictions. Details of risk minimization measures require verification against the original document.
Source
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Дермазол плюс, шампунь, ТОВ “Гледфарма ЛТД”, Україна.
Reviewed by: DrugCard editorial team ·
This article does not replace clinical judgement. Disclaimer
