| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
MedicinalProductDefinition
|
MedicinalProductDefinition | |||
identifier
|
1.. | |||
system
|
1.. | |||
value
|
1.. | |||
|
type
|
Regulatory type, e.g. Investigational or Authorized. | |||
|
domain
|
If this medicine applies to human or veterinary uses. Binding: Medicinal Product Domain ( example ) |
|||
|
version
|
A business identifier relating to a specific version of the product. | |||
|
status
|
The status within the lifecycle of this product record. | |||
|
statusDate
|
The date at which this status became applicable. | |||
|
description
|
General description of the medicinal product referred by the ePI | |||
|
combinedPharmaceuticalDoseForm
|
Binding: Dose Form ( example ) | |||
|
route
|
Binding: Route Of Administration ( example ) | |||
|
indication
|
Narrative text of the authorized indication(s) for this product. | |||
|
legalStatusOfSupply
|
The legal status of supply of the medicinal product as classified by the regulator. | |||
|
additionalMonitoringIndicator
|
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. | |||
|
specialMeasures
|
Whether the Medicinal Product is subject to special measures for regulatory reasons. | |||
|
pediatricUseIndicator
|
If authorised for pediatric use | |||
|
classification
|
Allows the product to be classified by various systems (e.g. ATC) | |||
|
marketingStatus
|
||||
|
country
|
Binding: ISO Country two letter code ( preferred ) | |||
|
status
|
Status of the marketing of the medicinal product. | |||
|
dateRange
|
The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder | |||
|
packagedMedicinalProduct
|
Package type for the product. | |||
|
contact
|
||||
|
type
|
Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. | |||
|
contact
|
A specific contact, person (in a role), or an organization for this product | |||
|
name
|
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productName
|
The full product name. | |||
|
type
|
Type of product name, such as rINN, Proprietary, Non-Proprietary | |||
|
part
|
||||
|
part
|
A fragment of a product name. | |||
|
type
|
Type for this part of the name (e.g. strength part) | |||
|
usage
|
||||
|
country
|
Country where this name applies | |||
|
jurisdiction
|
Jurisdiction where this name applies | |||
|
language
|
Language for this name | |||
|
Documentation for this format
|
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