Analysis of Administrative Decisions of Foreign Regulatory Authorities

Abstract

Analysis of administrative decisions of foreign regulatory authorities on the limitation of circulation of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profi le, conducted by experts of the Scientifi c Centre for Expert Evaluation of Medicinal Products revealed 27 administrative decisions of foreign regulatory authorities. These decisions contained information on the following medicines registered in Russia: sartans (irbesartan, candesartan, losartan, olmesartan), hydrochlorothiazide, dimethylfumarate, human normal immunoglobulin, omalizumab, tacrolimus, terifl unomide, tofacitinib, ustekinumab, fi ngolimod, everolimus, atezolizumab, pembrolizumab, vinorelbine, daratumumab, imatinib, ipilimumab, lenalidomide, lenvatinib, methotrexate and ramucirumab.

Keywords

• adverse reactions
• postmarketing studies
• security profi le
• drugs
• instructions for medical use
• pharmacovigilance