packaged pharmaceutical product
- Guideline or reference source
- ISO11616 IDMP Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
- Definition
- pharmaceutical product refers to the qualitative and quantitative composition of the pharmaceutical product as contained in the package of the medicinal product NOTE In many instances the packaged pharmaceutical medicinal product will be equal to the medicinal product. However, there are instances where e.g. the packaged pharmaceutical product(s) must be reconstituted before it can be administered to the patient (powder and solvent for solution for injection). EXAMPLE Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta (packaged pharmaceutical product). After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta (pharmaceutical product after reconstitution).
- Related Term
- packaged medicinal product
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