Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4566
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4566
Character Range: 2154548–2155951

4566                                      SODIUM CALCIUM EDETATE                                                                   E         When for oral use, sodium is a mandatory component of sodium calcium edetate.
                                                                                                                                             Sodium calcium edetate must only be included in medicines when:
                                                                                                                                             (a) the route of administration is limited to topical for dermal use; or
                                                                                                                                             (b) in combination with other permitted ingredients as a flavour proprietary excipient formulation.
                                                                                                                                             The total concentration of sodium calcium edetate in the medicine must not exceed 0.32%.
                                                                                                                                             The total concentration of flavour proprietary excipient formulations containing sodium calcium edetate must not be more than 5% of the total medicine.