Indication/Intended Use PDS Attributes
| Attribute | Description |
|---|---|
| Application Code | The code of the application with which the indication is associated. |
| Application Name | The name of the application with which the indication is associated. |
| Countries | Country (countries) for which the detail is created. The countries available for selection are all countries associated with the Application. The exceptions are application countries with the Withdraw Date value equal to today’s date or earlier. Such countries are not available for selection in the
Countries multi-select field on the
Add/Modify Indication/Intended Use page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.
If several countries are selected, they are displayed as comma-separated on the View detail page. Defines the value that is included to the XML file during the XEVMPD Submission Wizard execution. Note: By default, all countries associated to the Application appear in the
Selected box of the
Countries field on the
Add Indication/Intended Use page.
|
| Date QC'd | The date the QC Status was set. |
| Family Code | The code of the product family with which the indication is associated. |
| Family Name | The name of the product family with which the indication is associated. |
| Indications | Selected indications for this detail, for example a migraine or stroke. |
| Comorbidity | Any co-morbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information. |
| Intended Effect | The intended effect can be the part of the indication that describes the result/type of outcome intended for the target condition. |
| Indication/Intended Use Comments | Text area where you can enter comments about the indication. |
| Indication/Intended Use Description | Text area where you can enter a description about the indication. |
| Indication/Intended Use Keywords | Area where you can enter text for searching purposes. |
| Indication/Intended Use Last Updated | The date the indication/intended use was last changed. |
| Indication/Intended Use Status | The status of the entity. |
| Indication/Intended Use Status Date | The date on which the status of the detail was set. |
| Product Detail Set Name | The name of the PDS with which the indication is associated. |
| Product Name | The name of the product with which the indication is associated. |
| QC Status | QC Status of the detail. |
| QC'd by | Person logged on to the system who set the QC Status for the detail to QC Passed or QC Failed. |