Drug Safety Monitoring Information

Analysis of administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for Expert Evaluation of Medicinal Products reveal...

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Main Authors: E. V. Shubnikova, E. O. Zhuravleva, N. Yu. Velts, P. M. Giulakhmedova, A. A. Druzhinina
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2021-07-01
Series:Безопасность и риск фармакотерапии
Subjects:
Online Access:https://www.risksafety.ru/jour/article/view/218
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author E. V. Shubnikova
E. O. Zhuravleva
N. Yu. Velts
P. M. Giulakhmedova
A. A. Druzhinina
author_facet E. V. Shubnikova
E. O. Zhuravleva
N. Yu. Velts
P. M. Giulakhmedova
A. A. Druzhinina
author_sort E. V. Shubnikova
collection DOAJ
description Analysis of administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for Expert Evaluation of Medicinal Products revealed 19 administrative decisions. These decisions contained information on the following medicines registered in Russia: amikacin, tobramycin, gentamicin, neomycin, ciprofloxacin, delafloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, rufloxacin, сeftriaxone, ceftaroline, rifapentine, tigecycline, bacitracin, ertapenem, daptomycin, erythromycin, fosfomycin, ampicillin+sulbactam, chloroquine, hydroxychloroquine.
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spelling doaj.art-004bd778d7aa43728223c38b54e6c15e2025-03-02T10:50:04ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642021-07-019210310510.30895/2312-7821-2021-9-2-103-105186Drug Safety Monitoring InformationE. V. Shubnikova0E. O. Zhuravleva1N. Yu. Velts2P. M. Giulakhmedova3A. A. Druzhinina4Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsAnalysis of administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for Expert Evaluation of Medicinal Products revealed 19 administrative decisions. These decisions contained information on the following medicines registered in Russia: amikacin, tobramycin, gentamicin, neomycin, ciprofloxacin, delafloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, rufloxacin, сeftriaxone, ceftaroline, rifapentine, tigecycline, bacitracin, ertapenem, daptomycin, erythromycin, fosfomycin, ampicillin+sulbactam, chloroquine, hydroxychloroquine.https://www.risksafety.ru/jour/article/view/218adverse reactionspostmarketing studiessecurity profiledrugsinstructions for medical usepharmacovigilance
spellingShingle E. V. Shubnikova
E. O. Zhuravleva
N. Yu. Velts
P. M. Giulakhmedova
A. A. Druzhinina
Drug Safety Monitoring Information
Безопасность и риск фармакотерапии
adverse reactions
postmarketing studies
security profile
drugs
instructions for medical use
pharmacovigilance
title Drug Safety Monitoring Information
title_full Drug Safety Monitoring Information
title_fullStr Drug Safety Monitoring Information
title_full_unstemmed Drug Safety Monitoring Information
title_short Drug Safety Monitoring Information
title_sort drug safety monitoring information
topic adverse reactions
postmarketing studies
security profile
drugs
instructions for medical use
pharmacovigilance
url https://www.risksafety.ru/jour/article/view/218
work_keys_str_mv AT evshubnikova drugsafetymonitoringinformation
AT eozhuravleva drugsafetymonitoringinformation
AT nyuvelts drugsafetymonitoringinformation
AT pmgiulakhmedova drugsafetymonitoringinformation
AT aadruzhinina drugsafetymonitoringinformation