Drug Safety Monitoring—International 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 limiting the use of some medicinal products and/or the need to introduce changes in patie...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2020-12-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/204 |
| _version_ | 1797224635787378688 |
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| author | E. V. Shubnikova T. M. Bukatina G. V. Kutekhova |
| author_facet | E. V. Shubnikova T. M. Bukatina G. V. Kutekhova |
| author_sort | E. V. Shubnikova |
| collection | DOAJ |
| description | 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 limiting the use of some medicinal products and/or the need to introduce changes in patient information leaflets due to changes in the medicines’ safety profiles. The analysis helped to identify 16 administrative decisions that contain information on the following medicines registered in Russia: duloxetine, sertraline, paroxetine, сitalopram, desvenlafaxine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, venlafaxine, vortioxetine, mirtazapine, risperidone, clozapine, aripiprazole, quetiapine, olanzapine, lacosamide, gabapentin, pregabalin. |
| first_indexed | 2024-03-08T22:26:49Z |
| format | Article |
| id | doaj.art-de0442d8cae3492cbb42cdb933866786 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2024-04-24T13:56:15Z |
| publishDate | 2020-12-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj.art-de0442d8cae3492cbb42cdb9338667862024-04-03T17:56:37ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642020-12-018421121310.30895/2312-7821-2020-8-4-211-213176Drug Safety Monitoring—International InformationE. V. Shubnikova0T. M. Bukatina1G. V. Kutekhova2Scientific Centre for Expert Evaluation of Medicinal ProduсtsScientific Centre for Expert Evaluation of Medicinal ProduсtsScientific Centre for Expert Evaluation of Medicinal ProduсtsExperts 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 limiting the use of some medicinal products and/or the need to introduce changes in patient information leaflets due to changes in the medicines’ safety profiles. The analysis helped to identify 16 administrative decisions that contain information on the following medicines registered in Russia: duloxetine, sertraline, paroxetine, сitalopram, desvenlafaxine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, venlafaxine, vortioxetine, mirtazapine, risperidone, clozapine, aripiprazole, quetiapine, olanzapine, lacosamide, gabapentin, pregabalin.https://www.risksafety.ru/jour/article/view/204adverse reactionspostmarketing studiessafety profiledrugspatient information leafletpharmacovigilance |
| spellingShingle | E. V. Shubnikova T. M. Bukatina G. V. Kutekhova Drug Safety Monitoring—International Information Безопасность и риск фармакотерапии adverse reactions postmarketing studies safety profile drugs patient information leaflet pharmacovigilance |
| title | Drug Safety Monitoring—International Information |
| title_full | Drug Safety Monitoring—International Information |
| title_fullStr | Drug Safety Monitoring—International Information |
| title_full_unstemmed | Drug Safety Monitoring—International Information |
| title_short | Drug Safety Monitoring—International Information |
| title_sort | drug safety monitoring international information |
| topic | adverse reactions postmarketing studies safety profile drugs patient information leaflet pharmacovigilance |
| url | https://www.risksafety.ru/jour/article/view/204 |
| work_keys_str_mv | AT evshubnikova drugsafetymonitoringinternationalinformation AT tmbukatina drugsafetymonitoringinternationalinformation AT gvkutekhova drugsafetymonitoringinternationalinformation |