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 |
Compo nent Type |
Description | |
|
Com ponent 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). | |
|
Manu factured Item Name |
P, PMD, Vet, FV |
The name of manufactured item. This field is available for Reference Substance Attributes for Manufactured Item only. | |
|
Pharma ceutical 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. | |
| Attribute |
Compo nent Type |
Description | |
|
Substance Name |
P, PMD, Vet, FV |
The name of substance. | |
| Substance Type |
P, PMD, Vet, FV |
The substance type. | |
Table 7. 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. |
Table 7. Table 1. IDMP Presentation Strength (continued)
| Attribute |
Compo nent Type |
Description |
| Presentation Single/Low Limit Denominator - Unit of Presentation/Measurement |
P, PMD, Vet |
The value from Unit of Presentation and Unit of Measurement. |
|
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 8. Table 2. IDMP Concentration Strength
| Attribute |
Com ponent 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. |
Table 8. Table 2. IDMP Concentration Strength (continued)
| Attribute |
Com ponent Type |
Description |
|
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 :
◦ Presentation Single or Low Limit Unit of Measurement ◦ Presentation Single or Low Limit Unit of Presentation
◦ Presentation High Limit Unit of Measurement ◦ Presentation High Limit Unit of Presentation |
|
Concentration Strength |
a concatenation of :
◦ Concentration Single or Low Limit Unit of Measurement
|
| Attribute Name | Description |
|
◦ Concentration Single or Low Limit Unit of Measurement
◦ Concentration High Limit Unit of Measurement
◦ Concentration High Limit Unit of Measurement |