Active Ingredient Attributes

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

Attribute

Compo­

nent

Type

Description

Active Ingredient

Name

P,

PMD,

Vet,

FV

The name of the active ingredient. Drop-down list.Note: If Alternate IDMP Reference Active Ingredient is configured via overrides and populated with a unique value, the Active Ingredient field on the Create Active Ingredient page allows to select same substance values multiple times.

Alternate

IDMP

Active Ingredient

P,

PMD,

Vet,

FV

The name of the alternate IDMP active ingredient. This field is available for Pharmaceutical Product Active Ingredient attributes and Manufacturer Item Active Ingredients attributes only. You cannot modify the value selection after saving.

  • For Manufactured Item Active Ingredient: this field can be configured as a drop-down list with the values from the Component Reference Active Ingredients.
  • For Pharmaceutical Product Active Ingredient: this field can be configured as a drop-down list with the values from the Component Reference Active Ingredients of Components associated with a Pharmaceutical Product. To search for a Component Active Ingredient, you need to assign Components to Pharmaceutical Product.

This field can also be configured as the substance selection widget with all the active values from Data Administration > Substance Values. You can select only one value.

Note: For configuration assistance, please contact your Business Development Representative.

Attribute

Compo­

nent

Type

Description

Com­

ponent

Name

P,

PMD,

Vet,

FV

The component that contains the active ingredient. This filed is available for Active Ingredient Attributes for Component only.

Concen­

tration

Mea­

sure

Type

P,

PMD,

Vet

Used with other attributes to specify information about the concentration of the active ingredient. Values: Equal, Range, Up to, or Not Less Than. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

Exclude from

IDMP Submission

P,

PMD,

Vet,

FV

Indicates the presence or absence in IDMP Submission. Yes or No values. This field is available for Active Ingredient Attributes for Pharmaceutical Product only.

Family

Code

P,

PMD,

Vet,

FV

The company-specific code for the product family with which the active ingredient is associated.

Family

Name

P,

PMD,

Vet,

FV

The product family with which the active ingredient is associated.

Family

Type

P,

PMD,

Vet,

FV

The type of products in the product family with which the active ingredient is associated.

High

Amount Denom­

inator Prefix

P,

PMD,

Vet

The high limit amount denominator value. Must only be specified when a Range is described. Must be a Value from the published list. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

High

Amount

Denom­

P,

PMD,

Vet

The high limit amount denominator unit. Must only be specified when a Range is described. Must be a Value from the published list. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.
Attribute

Compo­

nent

Type

Description

inator

Unit

High

Amount Denom­

inator

Value

P,

PMD,

Vet

The high limit amount denominator value. Must only be specified when a Range is described. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

High

Amount Numer­

ator Prefix

P,

PMD,

Vet

The high limit amount numerator prefix must only be specified when a Range is described. Must be a Value from the published list. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

High

Amount Numer­

ator Unit

P,

PMD,

Vet

The high limit amount numerator unit must only be specified when a Range is described. Must be a Value from the published list. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

High

Amount Numer­

ator Value

P,

PMD,

Vet

The high limit amount numerator value. Must only be specified when a Range is described. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

Low

Amount Denom­

inator Prefix

P,

PMD,

Vet

The low limit amount denominator prefix or for non-range measurements the amount denominator prefix. Must be a Value from the published list. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

Low

Amount Denom­

inator Unit

P,

PMD,

Vet

The low limit denominator unit or for non-range measurements the amount numerator unit. Must be a Value from the published list. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

Low

Amount

Denom­

P,

PMD,

Vet

The low limit amount denominator value or for non-range measurements the amount denominator value. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.
Attribute

Compo­

nent

Type

Description

inator

Value

Low

Amount Numer­

ator Prefix

P,

PMD,

Vet

The low limit amount numerator prefix or for non-range measurements the amount numerator prefix. Must be a Value from the published list. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

Low

Amount Numer­

ator Unit

P,

PMD,

Vet

The low limit amount numerator unit or for non-range measurements the amount numerator unit. Must be a Value from the published list. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

Low

Amount Numer­

ator Value

P,

PMD,

Vet

The low limit amount numerator value or for non-range measurements the amount numerator value. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

Manu­

factured Item

Name

P,

PMD,

Vet,

FV

The name of manufactured item. This field is available for Active Ingredient Attributes for Manufactured Item only.
Measurement Point

P,

PMD,

Vet

The physical or logical location at which a condition is described. This field is available for the Active Ingredients Attributes of Component and Pharmaceutical Product only.

Product

Name

P,

PMD,

Vet,

FV

The product that contains the active ingredient.

Pharma­

ceutical

Product

Name

P,

PMD,

Vet,

FV

The standard pharmaceutical product name recognized internally and across countries. The product name must be unique. This field is available for Active Ingredient Attributes for Pharmaceutical Product only.
Attribute

Compo­

nent

Type

Description
Strength Same as Component?

P,

PMD,

Vet,

FV

Indicates if the Strength is the same as the Component with a Yes or No value. This field is available for Active Ingredients Attributes for Pharmaceutical Product and for Manufactured Item only.

Table 1. Table 1. IDMP Presentation Strength

Attribute

Compo­

nent

Type

Description
Strength (Presentation) Quantity Operator

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.Note: When Equal is selected, it is not displayed in the XEVMPD Strength , IDMP Presentation Strength , IDMP Concentration Strength columns on the related tabs.
Presentation Single/Low Limit  - Numerator Value

P,

PMD,

Vet

The Presentation Single or Low Limit Numerator Value.
Presentation Single/Low Limit Numerator - Unit of Measurement

P,

PMD,

Vet

The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
DP 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 Single/Low Limit Denominator Value

P,

PMD,

Vet

The value for Presentation Single/Low Limit Denominator.
Presentation Single/Low Limit Denominator  - Unit of Presentation/Measurement

P,

PMD,

Vet

The value from Unit of Presentation and Unit of Measurement.

Table 1. Table 1. IDMP Presentation Strength (continued)

Attribute

Compo­

nent

Type

Description

Presentation High

Limit Numerator Value

P,

PMD,

Vet

The Presentation High Limit Numerator Value.
Presentation High Limit Numerator  - Unit of Measurement

P,

PMD,

Vet

The Unit of Measurement is available for some of the attributes. Some of the values are: ml, mg.
DP 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.

Presentation High

Limit Denominator

Value

P,

PMD,

Vet

The value for Presentation High Limit Denominator.

Presentation High

Limit Denominator  - Unit of Presentation/Measurement

P,

PMD,

Vet

The value is taken from Unit of Presentation and Unit of Measurement.

Table 2. Table 2. IDMP Concentration Strength

Attribute

Compo­

nent

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.Note: When Equal is selected, it is not displayed in the XEVMPD Strength , IDMP Presentation Strength , IDMP Concentration Strength columns on the related tabs.

Concentration

Single or Low Limit Denominator Value

P,

PMD,

Vet

The Concentration Single or Low Limit Denominator Value.

Table 2. Table 2. IDMP Concentration Strength (continued)

Attribute

Compo­

nent

Type

Description

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 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
IDMP 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

Attribute Name Description

IDMP 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