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...
| Main Author: | |
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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»
2019-09-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/155 |
| _version_ | 1797224609256308736 |
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| author | Information relevant |
| author_facet | Information relevant |
| author_sort | Information relevant |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T22:27:22Z |
| format | Article |
| id | doaj.art-6529d9a1e9cd4c4386bb46d2a9bdb356 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2024-04-24T13:55:50Z |
| publishDate | 2019-09-01 |
| 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-6529d9a1e9cd4c4386bb46d2a9bdb3562024-04-03T17:56:36ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642019-09-017315215810.30895/2312-7821-2019-7-3-152-158144Analysis of Administrative Decisions of Foreign Regulatory AuthoritiesInformation relevantAnalysis 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.https://www.risksafety.ru/jour/article/view/155adverse reactionspostmarketing studiessecurity profi ledrugsinstructions for medical usepharmacovigilance |
| spellingShingle | Information relevant Analysis of Administrative Decisions of Foreign Regulatory Authorities Безопасность и риск фармакотерапии adverse reactions postmarketing studies security profi le drugs instructions for medical use pharmacovigilance |
| title | Analysis of Administrative Decisions of Foreign Regulatory Authorities |
| title_full | Analysis of Administrative Decisions of Foreign Regulatory Authorities |
| title_fullStr | Analysis of Administrative Decisions of Foreign Regulatory Authorities |
| title_full_unstemmed | Analysis of Administrative Decisions of Foreign Regulatory Authorities |
| title_short | Analysis of Administrative Decisions of Foreign Regulatory Authorities |
| title_sort | analysis of administrative decisions of foreign regulatory authorities |
| topic | adverse reactions postmarketing studies security profi le drugs instructions for medical use pharmacovigilance |
| url | https://www.risksafety.ru/jour/article/view/155 |
| work_keys_str_mv | AT informationrelevant analysisofadministrativedecisionsofforeignregulatoryauthorities |