Identified risk – an adverse consequence of pharmacotherapy for which sufficient evidence has been obtained of a causal relationship with the suspected medicinal product.*

*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.