| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
Ingredient
|
Ingredient | |||
for
|
1.. | Reference (PPL Medicinal Product profile | PPL Administrable Product profile | PPL Manufactured Item profile) | Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used | |
role
|
Role of the ingredient. Default is 100000072072|Active as PPL data normally only includes active ingredients. | |||
coding
|
||||
system
|
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072050 | |||
|
substance
|
Substance code from EMA SMS | |||
|
code
|
Binding: EMA SPOR SMS Substances ( required ) | |||
|
strength
|
1.. | |||
Slices for presentation[x]
|
Slice: Unordered, Open by type:$this | |||
presentation[x]:presentationRatio
|
0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | |
numerator
|
1.. | Binding: EMA SPOR Unit of Measurement ( required ) | ||
denominator
|
1.. |
Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined ( required ) |
||
|
Slices for concentration[x]
|
Slice: Unordered, Open by type:$this | |||
|
concentration[x]:concentrationRatio
|
0..1 | Ratio | Strength per unit of measurement (20mg/1ml) | |
|
numerator
|
1.. | Binding: EMA SPOR Unit of Measurement ( required ) | ||
|
denominator
|
1.. | Binding: EMA SPOR Unit of Measurement ( required ) | ||
|
referenceStrength
|
Strenth expressed in terms of a reference substance; reference strength type not distinguished. According to EMA IG, all products need to have reference strentgh (repeating the strentgh, if needed) | |||
|
substance
|
Substance code from EMA SMS Binding: EMA SPOR SMS Substances ( required ) |
|||
|
Slices for strength[x]
|
Slice: Unordered, Open by type:$this | |||
|
strength[x]:strengthRatio
|
0..1 | Ratio | ||
|
numerator
|
1.. | Binding: EMA SPOR Unit of Measurement ( required ) | ||
|
denominator
|
1.. |
Unit of measurement or unit of presentation Binding: EMA SPOR All Units Combined ( required ) |
||
|
Documentation for this format
|
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