Ennov InSight Registrations 7.3

Reference Substance Attributes

The following table lists the attributes for the reference substance. The attributes that are available to you depend on your security privileges.

Attribute Component Type Description
Component Name P, PMD, Vet, FV Name of the component associated.
Family Code P, PMD, Vet, FV The company-specific code for the product family.
Family Name P, PMD, Vet, FV The standard name recognized internally and across countries.
Family Type P, PMD, Vet, FV The type of products associated with this product family (for example: pharmaceutical, medical device).
Manufactured Item Name P, PMD, Vet, FV The name of manufactured item. This field is available for Reference Substance Attributes for Manufactured Item only.
Pharmaceutical Product Name P, PMD, Vet, FV The standard pharmaceutical product name recognized internally and across countries. The value for the product name is unique. This filed is available for Reference Substance Attributes for Pharmaceutical Product only.
Product Name P, PMD, Vet, FV The standard product name recognized internally and across countries. In some sections of the application, the product name is shown with the product code to identify a product. For example, Origine 390 could identify a product that has the name Origine and the code 390.
Reference Substance Name P, PMD, Vet, FV The name of the reference substance.
Substance Name P, PMD, Vet, FV The name of substance.
Substance Type P, PMD, Vet, FV The substance type.
Table 1. IDMP Presentation Strength
Attribute Component Type Description
Concentration Measure Type P, PMD, Vet, FV Equates to Quantity Operator in IDMP. Refers to values per unit being defined. Example: Equal, Range, Up to, Not Less Than.
Presentation Single or Low Limit Numerator Value P, PMD, Vet The Presentation Single or Low Limit Numerator Value.
Presentation Single or Low Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Presentation Single or Low Limit Unit of Presentation P, PMD, Vet The Unit of Presentation is available for some of the attributes. Some of the values are: Bottle, Tablet, Capsule.
Presentation High Limit Numerator Value P, PMD, Vet The Presentation High Limit Numerator Value.
Presentation High Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Presentation High Limit Unit of Presentation P, PMD, Vet The Unit of Presentation is available for some of the attributes. Some of the values are: Bottle, Tablet, Capsule.
Table 2. IDMP Concentration Strength
Attribute Component Type Description
Concentration Measure Type P, PMD, Vet, FV Used with other attributes to specify information about the quantity operator in IDMP. Values: Equal, Range, Up to, or Not Less Than.
Concentration Single or Low Limit Numerator Value P, PMD, Vet The Concentration Single or Low Limit Numerator Value.
Concentration Single or Low Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Concentration Single or Low Limit Denominator Value P, PMD, Vet The Concentration Single or Low Limit Denominator Value.
Concentration Single or Low Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Concentration High Limit Numerator Value P, PMD, Vet The Concentration High Limit Numerator Value.
Concentration High Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
Concentration High Limit Denominator Value P, PMD, Vet The Concentration High Limit Denominator Value.
Concentration High Limit Unit of Measurement P, PMD, Vet The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
The attributes shown in columns below are concatenations of some fields values defined above.
Attribute Name Description
Presentation Strength a concatenation of :
  • IDMP Concentration Measure Type
  • Presentation Single or Low Limit Numerator Value:
    • Presentation Single or Low Limit Unit of Measurement
    • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
    • Presentation High Limit Unit of Measurement
    • Presentation High Limit Unit of Presentation
Concentration Strength a concatenation of :
  • IDMP Concentration Measure Type
  • Concentration Single or Low Limit Numerator Value:
    • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
    • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
    • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
    • Concentration High Limit Unit of Measurement