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The representation of a medicinal product marketed product marketed by a single organisation (supplier) in a single jurisdiction under a single name (which may be a trade or brand name) and which contains the same set of active ingredient substances, regardless of any modification of those active ingredient substances. It is a subtype of, and real world equivalent to, the Medicinal Product Only (MP only) class in the international core.
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- Describing medication statements for a medication profile when the detail of the exact product used is not known; e.g., "patient states they used Ventolin for 5 years in childhood"
- Decision support and protocol/guideline management may have a use case for this class (for example, to change presentation or a strength within a product family)
- Pharmacovigilance (abstract representation of a manufactured medicinal product)
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The real medicinal product class is a grouper concept for products containing the same set of active ingredient substance(s) and marketed under the same name by the same supplier.
Single ingredient substance branded products
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The RMP "Zocor (product)" shown in a taxonomic view in Figure 2 below presents products marketed by Organon Pharma UK Limited under a single name (Zocor) and containing only simvastatin as the active ingredient substance , and showing shows the RCD concepts associated with it:
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Figure 2: Diagram showing a branded single ingredient substance real medicinal product and its supporting real clinical drug concepts (note, Note: not all possible real clinical drug concepts are shown.)
Single ingredient
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generic
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products
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For those products without a unique (i.e., invented) product name, where the product uses the international non-proprietary name of the active substance as its product name (i.e., so called " generic products"), extensions may choose not to populate the Real Medicinal Product classProduct class, as shown below, with each RCD being associated directly with the CD in the International content:
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Alternatively, for products without a unique (i.e. invented) product name ("generic products") a national extension may choose to populate the Real Medicinal Product using the generic name AND supplier, since since this gives a unique RMP concept, as shown below:
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One of the fundamentals of a Real Medicinal Product is that it represents a single set of active ingredient substances, reflecting its associated MP only class that also represents represents a single set of active ingredient substances, without dose form or strength information.
The RMP "Inegy (product)" shown in a taxonomic view in Figure 2 below presents products marketed by Organon Pharma UK Limited under a single name (Inegy) and containing only simvastatin AND ezetimibe as the active ingredient substances, and showing the RCD concepts associated with it:
Figure 5: Diagram Diagram showing a branded multi-ingredient substance real medicinal product and its supporting real clinical drug concepts concepts (note, not all possible real clinical drug concepts are shown)
Not all authorised medicinal products that share the same (invented) product name will relate to a Real Medicinal Product, especially for over the counter (OTC) medicines, where a commercial "brand family" may contain products with different active ingredient sets which would therefore have different MP only representations. For example: , some cough and cold product ranges span expectorant products, cough suppressants, antipyretics and decongestant products, with different sets of active ingredients in each , but all sharing the same brand name.
In the example below, the three real clinical drug products all share the same product name ("Benylin®") in one jurisdiction, but they do not relate to a single real medicinal product due to differences in their active ingredient substances.
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| Semantic tag | (real medicinal product) | |||||||||
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| Definition status |
Exceptions None identified | |||||||||
Attribute
| Range
Cardinality
Notes
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Attribute
| Range
Cardinality
Notes
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Attribute
| Range
Cardinality
Notes
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| Role Group | Attribute
| Range
Cardinality
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This attribute describes the set of active ingredient substances that the concept minimally contains. A set of active ingredient substances may well have only one member. | ||||||||
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Figure 10: Single active ingredient substance real medicinal product example inferred view
Example: multiple active ingredient substance branded product (Inegy):
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stated view followed by the inferred view
Figure 11: Multiple active ingredient substance real medicinal product example stated view
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There is no identified representation of a class similar to the Real Medicinal Product concept class in IDMP , despite there being (a possible) pharmacovigilance use case for this class.
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