Ivermectin

Dear applicants!

Based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing ivermectin (topical use), the Pharmacovigilance Risk Assessment Committee (PRAC) reached the following scientific conclusions:

Based on data on a case of acute hepatitis with a favorable clinical course reported during the period covered by the PSUR, as well as information on:

• pharmacokinetic properties that cause a significant systemic pharmacological effect of ivermectin when applied topically for the treatment of affected skin;
• known risk of increased ALT / alkaline phosphatase with oral use of ivermectin; holders of registration certificates for medicinal products containing ivermectin (topical use) should amend the section "Adverse reactions" of the instructions for medical use by adding information on:
  • increase in transaminases (ALT/AST) with frequency “unknown”.

List of medicinal products containing ivermectin (topical use) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 24.05.2019).

Linkhttps://www.ema.europa.eu/en/documents/psusa/ivermectin-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00010376/201804_en.pdf