Drug Safety Monitoring Information

Drug Safety Monitoring Information

Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need to amend the prescribing information due to chang...

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Bibliographic Details
Main Authors: Elena V. Shubnikova, Marya A. Darmostukova, Tatyana M. Bukatina
Format: Article
Language:Russian
Published: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation  2020-06-01
Series:Безопасность и риск фармакотерапии
Subjects:
adverse reactions
post-authorisation studies
security profile
medicinal products
prescribing information
pharmacovigilance
Online Access:https://www.risksafety.ru/jour/article/view/189
Description
Summary:Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need to amend the prescribing information due to changes in their safety profile. The analysis helped to identify 11 administrative decisions that contain information on the following medicines registered in Russia: ranitidine, nizatidine, famotidine, pantoprazole, ondansetron, domperidone.
ISSN:2312-7821
2619-1164

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