Medicinal Product and Medicinal Product Forms
When a clinical drug is created, the following supertypes must either already exist or must be created:
For example,
1172863005 Paracetamol 1 g oral tablet has the following supertypes:
These concepts in the International Release, their descriptions, and their
For example,
1204319004 |Product containing precisely retinol (as retinol palmitate) 50000 unit/1 milliliter conventional release solution for injection (clinical drug)| has medicinal product and medicinal product form supertypes with retinol, not retinol palmitate. Retinol palmitate is a modification of Retinol and thus should not be used in the creation of the medicinal product and medicinal product form supertypes.
Exceptions to use a modified substance are explicitly identified below:
Exceptions | Elucidation | Examples |
Benzylpenicillin | When the active ingredient has an Is modification of (attribute) value of 323389000 |Benzylpenicillin (substance)|. | 1234765004 |Product containing only benzathine benzylpenicillin in parenteral dose form (medicinal product form)| 323404007 |Product containing benzathine benzylpenicillin (medicinal product)| Benzylpenicillin is the base, but use the modified substance in the FSN for the MP/MPF. |
Chemical element compound with multiple modification | Instances where the chemical element compound has two or more Is Modification of (attribute)s | 422232005 |Calcium lactate gluconate (substance)|
1359973006 |Copper (64-Cu) labeled somatostatin analog (substance)|
|
Chloral hydrate | 273948005 |Chloral hydrate (substance)| is a modification of Chloral. However, chloral is unstable on its own and always exists in the hydrated form. | 778711000 |Product containing only chloral hydrate in oral dose form (medicinal product form)| 386735001 |Product containing chloral hydrate in oral dose form (medicinal product form)| 775158004 |Product containing only chloral hydrate (medicinal product)| |
Liposome or lipid complex substances | < 414612001 |Liposomal agent (substance) These subtypes have some sort of modification, but they can be used to create:
Do not use to create:
| 426490000 |Vincristine liposome (substance)| 425953004 |Amphotericin B lipid complex (substance)| 768664009 |Amphotericin B phospholipid complex (substance)| 427544000 |Amphotericin B cholesteryl sulfate complex (substance)| |
Pegylated substance | There is no technical way to identify these concepts, though they will often begin with peg-. | 385544005 |Pegfilgrastim (substance)| 770965008 |Pegvaliase (substance)| |
Radiopharmaceutical | < 89457008 Radioactive isotope (substance)| | 783865003 |Product containing only cyanocobalamin (58-Co) (medicinal product)| 783867006 |Product containing only cyanocobalamin (58-Co) in oral dose form (medicinal product form)| 783856005 |Product containing sodium iodide (131-I) in parenteral dose form (medicinal product form)| 783854008 |Product containing sodium iodide (131-I) (medicinal product)| |
Silver sulfadiazine | 387112002 |Silver sulfadiazine (substance)| is a modification of 74523009 |Sulfadiazine (substance)|. | 864009007 |Product containing only silver sulfadiazine in cutaneous dose form (medicinal product form)| 771756000 |Product containing silver sulfadiazine in cutaneous dose form (medicinal product form)| |
Sodium valproate | 387481005 |Sodium valproate (substance)| is a modification of 387080000 |Valproic acid (substance)|. | 766519009 |Product containing precisely sodium valproate 40 milligram/1 milliliter conventional release oral solution (clinical drug)| 1204386001 |Product containing precisely sodium valproate 133 milligram and valproic acid 58 milligram/1 each prolonged-release oral tablet (clinical drug)| |
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