Version 2.78

Term Description

A section to capture the company's applicant requirements for standardizing the risk evaluation and mitigation strategies (REMS) information for inclusion into pharmacy systems.
Source: Regenstrief LOINC

Fully-Specified Name

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

Additional Names

Long Common Name
FDA package insert REMS applicant requirements
Short Name
FDA insert REMS applic requirements

Basic Attributes

Class
DOC.REF
Type
Clinical
First Released
Version 2.63
Last Updated
Version 2.63
Order vs. Observation
Observation

Language Variants Get Info

Tag Language Translation
es-MX Spanish (Mexico) Requisitos del solicitante de REMS:-:-:^ Prospecto de la FDA:Narrativo:
it-IT Italian (Italy) REMS, requisiti del richiedente:-:-:^FDA, foglio illustrativo:Nar:
Synonyms: Documentazione di riferimento Foglio illustrativo della Food and Drug Administra Requisiti del richiedente REMS
zh-CN Chinese (China) REMS 申请者要求:-:-:^FDA 包装说明书:叙述型:
Synonyms: REMS 申请者（申请方、申请人）要求（需求、条件、条件要求）;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

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CodeSystem lookup
https://fhir.loinc.org/CodeSystem/$lookup?system=http://loinc.org&code=87526-0