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Overview

The |Product containing only x in y dose form (medicinal product form)| is an abstract representation of the active ingredient(s) and dose form intended site for a medicinal product. The medicinal product must contain only the active ingredient(s) specified in the FSN but may also contain a modification of the active ingredient(s) specified in the FSN.

Example:

  • Product containing only axitinib in oral dose form (medicinal product form)
  • Product containing only abacavir and lamivudine in oral dose form (medicinal product form)

Modeling

Stated parent concept

763158003 |Medicinal product (product)|

Semantic tag(medicinal product form)
Definition status900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)|

Attribute:

Has active ingredient

Range: <105590001|Substance (substance)|, excluding concepts representing structural groupers, dispositions, or combined substances

Cardinality:  1..*

There is no technical limit on the number of Has active ingredient attributes that may be added to a concept; a practical limit may be imposed at a later date.

Attribute:

Has manufactured dose form

Range: 736542009 |Pharmaceutical dose form (dose form) - descendants that are groupers representing intended site only (e.g. 385268001 |Oral dose form (dose form)|, 385287007 |Parenteral dose form (dose form)|)

Cardinality: 1..1

Exceptions: 

    • 385217004 |Conventional release gas for inhalation (dose form)| may be used as manufactured dose form for Medicinal product form concepts.
    • 785898006 |Conventional release solution for irrigation (dose form)| does not have 736474004 |Has dose form intended site (attribute)| but can be used as a target for manufactured dose form for Medicinal product form concepts.

Attribute:

Count of base of active ingredient

Concrete Type: Integer

Range: >#0..

Cardinality: 1..1

Naming Guidelines

FSN

Use the following pattern for the FSN; align naming and case sensitivity with the FSN for the concepts that are selected as the attribute value, excluding the semantic tag. For multiple ingredient drug products, the active ingredients must be in alphabetical order and separated by the word “and”.

  • Product containing only <Active ingredient FSN> in <Manufactured dose form FSN> (medicinal product form)
  • Product containing only <Active ingredient FSN> and <Active ingredient> in <Manufactured dose form FSN>(medicinal product form)
  • Product containing only <Active ingredient FSN> and <Active ingredient FSN> and <Active ingredient FSN> in <Manufactured dose form FSN> (medicinal product form)

Creation of MPF-only concepts for all possible combinations of active ingredients contained in multiple ingredient products is not recommended at this time (no specific use case has been identified). For example, a product containing three active ingredients would only require creation of one MPF-only concept. If any of the active ingredients is available as a single ingredient product, or as part of another multiple ingredient concept, then appropriate concepts would be created for those products.

For example,

      • Product containing only axitinib in oral dose form (medicinal product form)
      • Product containing only abacavir and lamivudine in oral dose form (medicinal product form)
      • Product containing only abacavir and lamivudine and zidovudine in oral dose form (medicinal product form)

Preferred Term

Use the following pattern for the PT; align naming and case sensitivity with the PT for the concept that is selected as the attribute value. For multiple ingredient drug products, the active ingredients must be in alphabetical order and separated by the word “and”.

  • <Active ingredient PT> only product in <Manufactured dose form PT>
  • <Active ingredient PT>and <Active ingredient PT> only product in <Manufactured dose form PT>
  • <Active ingredient PT>and <Active ingredient PT>and <Active ingredient PT> only product in <Manufactured dose form PT>

For example,

      • Axitinib only product in oral dose form
      • Abacavir and lamivudine only product in oral dose form
      • Abacavir and lamivudine and zidovudine only product in oral dose form
Synonym

Synonyms matching the FSN are not required.

Exemplars

The following illustrates the stated view for 773392006 |Product containing only axitinib in oral dose form (medicinal product form)|:

The following illustrates the inferred view for 773392006 |Product containing only axitinib in oral dose form (medicinal product form)|:

The following illustrates the stated view for 772249008 |Product containing only abacavir and lamivudine in oral dose form (medicinal product form)|:

The following illustrates the inferred view for 772249008 |Product containing only abacavir and lamivudine in oral dose form (medicinal product form)|:



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