Version 2.78

Part Description

LP221176-3   REMS elements to assure safe use
A section to capture the elements to ensure safe use, for standardizing the risk evaluation and mitigation strategies (REMS) information for inclusion into pharmacy systems. Source: U.S. Food and Drug Administration

Fully-Specified Name

Component
REMS elements to assure safe use
Property
-
Time
-
System
^FDA package insert
Scale
Nar
Method

Additional Names

Short Name
FDA insert REMS elmnts assure safe use

Basic Attributes

Class
DOC.REF
Type
Clinical
First Released
Version 2.58
Last Updated
Version 2.58
Order vs. Observation
Observation

Language Variants Get Info

Tag Language Translation
es-MX Spanish (Mexico) Elementos REMS para garantizar un uso seguro:-:-:^ Prospecto de la FDA:Narrativo:
it-IT Italian (Italy) REMS, elementi per garantire l'uso sicuro:-:-:^FDA, foglio illustrativo:Nar:
Synonyms: Documentazione di riferimento Elementi per garantire l''uso sicuro REMS Elementi REMS Foglio illustrativo della Food and Drug Administra
zh-CN Chinese (China) 旨在保证安全使用的 REMS 元素:-:-:^FDA 包装说明书:叙述型:
Synonyms: REMS 元素（要素、因素）;风险（危险）评价（评估）与缓解（减缓、减轻、降低、对应）策略;风险评价与缓解策略;风险评价（评估、测评、评测、评判、评定、判定、评量、核定）与缓解（减轻、降低、减灾、处理、应对）策略;risk evaluation and mitigation strategies;REMS SPL;结构化产品标签;结构化产品标签;Structured Product Labelling;结构化产品标记;结构化产品标识;美国食品及药品管理局包装说明书;超系统 - FDA 包装说明书;食品及药品管理局包装说明书;FDA 包装插页 参考文件;参考文档;引用文件;引用文档;文件.参考;文件.引用;文档.引用 叙述;叙述性文字;报告;报告型;文字叙述;文本叙述型;文本描述;文本描述型 旨在保证（确保）安全使用的 REMS 元素（要素、因素）;风险（危险）评价（评估）与缓解（减缓、减轻、降低、对应）策略;风险评价与缓解策略;风险评价（评估、测评、评测、评判、评定、判定、评量、核定）与缓解（减轻、降低、减灾、处理、应对）策略;risk evaluation and mitigation strategies;REMS

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