Regulatory
Published · Updated · 1 min read
DEC: mupirocin risk management plan provides for routine pharmacovigilance
What it means for practice
Refer to the safety information in the instructions for medical use and report suspected adverse reactions as part of routine pharmacovigilance.
Summary
The website of the State Expert Centre of the Ministry of Health of Ukraine hosts a risk management plan summary for Baktopik, a mupirocin ointment manufactured by KUSUM LLC, Ukraine. According to the abstract attached to the link, the medicine is used to treat bacterial skin infections, including impetigo and folliculitis.
Safety information
The abstract reports that no identified or potential risks or missing safety information are currently noted. Safety information for topical mupirocin is consistent with that of the reference medicinal product. No additional post-authorisation studies are planned.
Risk management measures
The plan describes routine risk minimisation measures: information in the instructions for medical use and on the packaging. Routine pharmacovigilance includes collecting and analysing adverse reaction reports.
The described approach therefore relies on information measures and continued safety monitoring. The supplied abstract provides no quantitative data on adverse reaction frequencies or results of comparative safety assessments. Risk management plan summary.
Source
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Бактопік, мазь, ТОВ “КУСУМ”, Україна.
Reviewed by: DrugCard editorial team ·
This article does not replace clinical judgement. Disclaimer
