Safety of Antibacterial and Antiprotozoal Medicinal Products

Abstract

The experts of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recalls of antibacterial and antiprotozoal medicinal products and/or the need for labelling updates due to changes in the safety profile. The analysis revealed 16 decisions containing information on the following medicines registered in Russia: ertapenem, сeftriaxone, cefazolin, аmoxicillin, сefoperazone+sulbactam, piperacillin+tazobactam, сlindamycin, teicoplanin, rifampin, co-trimoxazole, hydroxychloroquine.

Keywords

• adverse drug reactions
• post-marketing studies
• safety profile
• medicinal products
• antibacterials
• antiprotozoals
• labelling
• pharmacovigilance