Individual Case Safety Report (ICSR) – information transmitted in accordance with established format and content regarding one or more suspected adverse reactions to a medicinal product occurring in a single patient at a specific point in time.*

*Decision No. 87 of the Council of the Eurasian Economic Commission dated November 3, 2016 “On Approval of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union” (as amended by Decision No. 81 of the Council of the Eurasian Economic Commission dated May 19, 2022). Effective date — December 6, 2022.