| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
Ingredient
|
Ingredient | |||
for
|
Reference (Processing Profile - Medicinal Product | Processing Profile - Administrable Product | Processing Profile - Manufactured Item) | Reference to the medicinal product, pharmaceutical product and/or manufactured item where the ingredient is used | ||
role
|
Role of the ingredient. PPL data normally only includes active ingredients. | |||
substance
|
Substance code from EMA SMS | |||
code
|
Binding: EMA SPOR SMS Substances ( example ) | |||
|
strength
|
||||
Slices for presentation[x]
|
Slice: Unordered, Open by type:$this | |||
presentation[x]:presentationRatio
|
0..1 | Ratio | Strength per unit of presentation (10mg/vial or 10mg/0.5ml where 0.5ml is the size of the vial) | |
|
Slices for concentration[x]
|
Slice: Unordered, Open by type:$this | |||
|
concentration[x]:concentrationRatio
|
0..1 | Ratio | Strength per unit of measurement (20mg/1ml) | |
|
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 ( example ) |
|||
|
Documentation for this format
|
||||