| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
Composition
|
Composition | |||
identifier
|
1.. | Unique identifier only for this version of the Composition | ||
system
|
1.. | |||
value
|
1.. | |||
|
version
|
An explicitly assigned identifer of a variation of the content in the ePI | |||
|
status
|
preliminary|final|amended|entered-in-error|deprecated | |||
|
type
|
Type of ePI document template | |||
|
category
|
Categorization of ePI | |||
subject
|
Reference (MedicinalProductDefinition (ePI)) | The authorized medicinal product(s) that this ePI's composition is about | ||
|
date
|
Date of last revision for this version of the authorized ePI. | |||
|
author
|
Reference (Organization (ePI)) | The Organization responsible for the ePI | ||
|
title
|
Title of the ePI Document | |||
|
relatesTo
|
Cross-reference to anotherother ePI compositions or ePI document()s) | |||
|
section
|
1.. | Level 1 section heading for the whole ePI | ||
title
|
1.. | Section heading defined by the market authorization holder | ||
|
code
|
1.. |
Section heading defined by the health authority. Cannot be changed by the market authorization holder Binding: Section Codes ( example ) |
||
|
text
|
Narrative text for this section (e.g., paragraphs, bulleted lists, tables). | |||
|
emptyReason
|
Reason the section is empty. | |||
section
|
BackboneElement | Nested sub-section headings for level 2, 3, 4 or 5. | ||
|
title
|
1.. | Section heading defined by the market authorization holder | ||
|
code
|
1.. |
Coded section heading defined by the health authority. Binding: Section Codes ( example ) |
||
|
text
|
Narrative text for this section. | |||
|
emptyReason
|
Reason the section is empty. | |||
|
Documentation for this format
|
||||