Part B – Information requests for specific product types

Page last updated: September 2016

Product type 1 – Fixed-dose combination products

This subsection applies to a submission for a fixed-dose combination of active component medicines seeking subsidisation under the PBS or the National Immunisation Program (NIP). It applies both to a combination of medicines in a single dosage form and to individual dosage forms in composite packaging.

Address all the information requests in this section. Explain and justify where an information request is not addressed. Explain, and present evidence for, the value of the fixed-dose combination product compared with the use of the individual components.

This subsection does not apply to medicines that – for specific indications – are almost invariably used together in fixed-dose combinations for clinical reasons, such as oral contraceptives, hormone replacement therapy and Helicobacter pylori eradication regimens.

Ensure that the labelling of the combination product clearly identifies the component-generic medicines.