About: Combination Product

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An Entity of Type : owl:Class, within Data Space : linked.opendata.cz associated with source document(s)

Attributes	Values
rdf:type	Class
rdfs:label	Combination Product
rdfs:subClassOf	Regulated Medical Product
Concept_In_Subset	Individual Case Safety Report Terminology Product Characteristic ICSR Terminology
Semantic_Type	Manufactured Object
Preferred_Name	Combination Product
UMLS_CUI	C1880146
Contributing_Source	FDA
Legacy_Concept_Name	Combination_Product
FULL_SYN	Combination Medical ProductSYNCI Combination ProductPTFDA Combination ProductPTNCI
DEFINITION	A product comprised of two or more regulated components, i.e., drug and device, biologic and device, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; or two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; or a drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.NCI
code	C54696
is rdfs:subClassOf of	Type 1: Convenience Kit of Co-Package Type 2: Prefilled Drug Delivery Device/System Type 3: Prefilled Biologic Delivery Device/System Type 4: Device Coated/Impregnated/Otherwise Combined with Drug Type 5: Device Coated or Otherwise Combined with Biologic Type 6: Drug/Biologic Combination Type 7: Separate Products Requiring Cross Labeling Type 8: Possible Combination Based on Cross Labeling of Separate Products Type 9: Other Type of Part 3 Combination Product

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