| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
RegulatedAuthorization
|
RegulatedAuthorization | |||
identifier
|
1.. | Identifier assigned by the health authority to a single medicinal product | ||
system
|
1.. | |||
value
|
1.. | |||
subject
|
1.. | Reference (MedicinalProductDefinition (ePI)) | ||
|
type
|
Overall type of this authorization, for example drug marketing approval, orphan drug designation. | |||
|
description
|
Brief description of the authorization | |||
|
region
|
Binding: ISO Country two letter code ( preferred ) | |||
|
status
|
The current status of this authorization | |||
|
statusDate
|
The date at which the current status was assigned. | |||
|
indication
|
CodeableReference (ClinicalUseDefinition Indication (ePI)) | Reference to the Clinical Use Definition | ||
|
reference
|
1.. | |||
|
holder
|
1.. | Reference (Organization (ePI)) | ||
|
regulator
|
Reference (Organization (ePI)) | |||
|
case
|
||||
identifier
|
Identifier by which this case can be referenced. | |||
|
type
|
The defining type of case. | |||
|
status
|
The status associated with the case. | |||
|
date[x]
|
Relevant date for this case. | |||
|
Documentation for this format
|
||||