Emerging safety issue – a safety issue assessed by the marketing authorization holder as requiring urgent attention from the competent authority in the field of pharmacovigilance due to its potential significant impact on the benefit-risk balance of the medicinal product and/or on patient health or public health, and due to the potential need for immediate regulatory action and communication to patients and healthcare professionals.*

*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.