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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.

LOINC Names Get Info

Fully-Specified Name
REMS applicant requirements:-:-:^FDA package insert:Nar:
Long Common Name
FDA package insert REMS applicant requirements
Short Name
FDA insert REMS applic requirements

Part Model Get Info

  • Component
    REMS applicant requirements
    LP263203-4
    • Analyte
      REMS applicant requirements
      LP263203-4
      • Component Numerator
        REMS applicant requirements
        LP263203-4
        • Component Numerator Core
          REMS applicant requirements
          LP263203-4
        • Component Numerator Core Suffix
          NULL
           
      • Component Denominator
        NULL
         
        • Component Denominator Core
          NULL
           
        • Component Denominator Core Suffix
          NULL
           
    • Challenge
      NULL
       
    • Adjustment
      NULL
       
    • Count
      NULL
       
  • Property
    -
    LP6769-6
  • Time
    -
    LP70420-2
  • System
    ^FDA package insert
    LP281754-4
    • System Core
      NULL
       
    • Super System
      FDA package insert
      LP36024-5
  • Scale
    Nar
    LP7749-7
  • Method
    NULL
     

Basic Attributes

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

Language Variants Get Info

TagLanguageTranslation
el-GRGreek (Greece)Απαιτήσεις αιτούντων REMS:-:-:^Ένθετο συσκευασίας FDA:Nar:
Synonyms: - DOC.REF Nar Απαιτήσεις αιτούντων REMS Ένθετο συσκευασίας FDA
es-MXSpanish (Mexico)Requisitos del solicitante de REMS:-:-:^ Prospecto de la FDA:Narrativo:
it-ITItalian (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-CNChinese (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

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

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