An adverse reaction is considered expected if the nature or severity of its manifestations is consistent with the available information about the medicinal product, vaccine, or tuberculin specified in the instructions for medical use/summary of product characteristics of the medicinal product, vaccine, or tuberculin.
Regulatory references: Section I of the Procedure for Pharmacovigilance, approved by order of the Ministry of Health of Ukraine No. 898 dated 27 December 2006, registered with the Ministry of Justice of Ukraine on 19 December 2016 under No. 1649/29779 (as amended by order of the Ministry of Health of Ukraine No. 996 dated 26 September 2016).
