Analysis of Administrative Decisions of Foreign Regulatory Authorities

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 Me...

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Bibliographic Details
Main Author: Information relevant
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2019-09-01
Series:Безопасность и риск фармакотерапии
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Online Access:https://www.risksafety.ru/jour/article/view/155
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Summary: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.
ISSN:2312-7821
2619-1164