Preferred Label : Combination Product;
NCIt synonyms : Combination Medical Product;
NCIt 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.;
Alternative definition : CDISC-GLOSS: A product composed of two or more different types of medical products
(i.e., a combination of a drug, device, and/or biological product with one another
and are referred to as constituent parts of the combination product). NOTE: A combination
product might be a single-entity product, a co-packaged product or a cross-labeled
product. [After 21 CFR 3.2 (e)] See also single-entity product, co-packaged product,
cross-labeled product.;
Origin ID : C54696;
UMLS CUI : C1880146;
Semantic type(s)
- concept_is_in_subset
