Orphan Designation Attributes
Use the description for the orphan designation attributes in the following table.
| Attribute | Description |
|
Application Code |
Agency-identified application number (or identifier). Can be the internal code until it is provided by the agency. |
|
Application Name |
The name of the application. |
| Community Registered Orphan Indication | The orphan designation indication that is registered in the community register. |
| Indications | The list of indications based on the product families selected.Note: When the Indications are selected in the Orphan Designation page, they are moved to the Assigned Indications section in Product Families. Their selection cannot be cancelled from a Product Family until cleared from an Orphan Designation. |
|
Market Exclusivity Start Date |
Defines the validity start date of the market exclusivity of the orphan medicinal product. Date of validity of the market exclusivity of the orphan medicinal product can be found in the individual product entry at the European Commission Register of medicinal product. |
| Number | Orphan designation number. Must be a unique value within an application. |
|
Orphan Designation Comments |
The discussion thread that includes all comments entered by users; includes the date and time the comments were entered and the user ID of the person who entered them. |
| Orphan Designation Description | The description of the Orphan Designation. |
|
Orphan Designation Keywords |
Keywords you can use to search for the Orphan Designation. |
| Orphan Status | Indicates if the product authorised in a jurisdiction is qualified as an orphan drug. |
| Orphan Status Date | The date the orphan designation statusof the medicinal product is assigned or modified. |