| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
MedicinalProduct
|
Base |
Medication This logical model cannot be the target of a reference |
||
medicinalProductIdentifier
|
0..* | Element |
MPID or national identifier |
|
|
packagedProductIdentifier
|
0..* | Element |
PCID or national |
|
|
pharmaceuticalProductIdentifier
|
0..* | Element |
PhPID or national virtual/administrable product code |
|
|
code
|
0..1 | Element | Medication code from a terminology | |
|
atc
|
0..1 | Element | ATC code | |
|
classification
|
0..* | Element |
Classification (narcotic/psychotropic; orphan drug; etc) |
|
|
packSize
|
0..* | Element |
Overall amount of product in one virtual or real package (100ml; 20 tablets; 1 creme & 6 pessaries) |
|
|
productName
|
0..* | BackboneElement |
Name of the product (full name, invented name, other) |
|
name
|
1..1 | Element | Name of type and language that is relevant for the users | |
|
language
|
0..1 | Element | Language of the name | |
type
|
0..1 | Element | Type of the name (full name, common name, etc) | |
|
doseForm
|
0..* | BackboneElement |
Dose form(s) on a product level. Dose form for a single package item is defined below. |
|
|
formCode
|
1..1 | Element | Coded dose form | |
|
type
|
0..1 | Element | The type of dose form (combined, authorised, administrable...) | |
|
item
|
0..* | BackboneElement |
A medication item. For combination packs, this can be manufactured items with each item having its own dose form and ingredients+strengths defined |
|
|
doseForm
|
0..1 | BackboneElement | Dose form of single item | |
|
formCode
|
1..1 | Element | Dose form | |
|
type
|
0..1 | Element | The type of dose form (typically manufactured dose form) | |
|
ingredient
|
1..* | BackboneElement |
Ingredients |
|
|
role
|
0..1 | Element | Role (active ingredient, excipient). Typically excipients are not needed, so by default active ingredients are expected. | |
|
substance
|
1..1 | Element | Substance | |
|
strengthInfo
|
1..* | BackboneElement |
Concentration or presentation strength |
|
strength
|
1..1 | Element | Concentration or presentation strength of the precise active ingredient | |
|
strengthType
|
1..1 | Element | Type of strength that is expressed | |
|
strengthSubstance
|
0..1 | Element | Substance that the strength refers to, if different from the main substance | |
|
unitOfPresentation
|
0..* | Element |
Unit of presentation for the manufactured item (tablet, vial, tube). Typically, the smallest countable object in the package. |
|
|
containedQuantity
|
0..1 | Element | Manufactured item quantity for liquids (3ml/vial) | |
|
manufacturedItemQuantity
|
0..1 | Element | Number of such manufactured items in this product (5 vials) | |
|
device
|
0..* | BackboneElement |
Administrative device included in the product |
|
|
deviceQuantity
|
1..1 | Element | Number of such devices | |
|
device
|
1..1 | Element | Device coded | |
|
marketingAuthorisationHolder
|
0..1 | Element | MAH name - do we need more? | |
|
routeOfAdministration
|
0..* | Element |
Route of Administration - if we need it on product level |
|
|
Documentation for this format
|
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