Version 2.78

Part Description

LP221178-9   REMS summary
The risk evaluation and mitigation strategies (REMS) Summary is an overview of what stakeholders who participate in REMS with ETASU, such as healthcare providers, patients, and distributors, are required to do under the REMS' Elements to Assure Safe Use and Implementation System. Source: U.S. Food and Drug Administration

Fully-Specified Name

Component
REMS summary
Property
-
Time
-
System
^FDA package insert
Scale
Nar
Method

Additional Names

Short Name
FDA insert REMS summary

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) Resumen de REMS:-:-:^ Prospecto de la FDA:Narrativo:
it-IT Italian (Italy) REMS, sintesi:-:-:^FDA, foglio illustrativo:Nar:
Synonyms: Documentazione di riferimento Foglio illustrativo della Food and Drug Administra Sintesi REMS
zh-CN Chinese (China) REMS 摘要:-:-:^FDA 包装说明书:叙述型:
Synonyms: REMS 摘要（小结）;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

LOINC Terminology Service (API) using HL7® FHIR® Get Info

CodeSystem lookup
https://fhir.loinc.org/CodeSystem/$lookup?system=http://loinc.org&code=82347-6