Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_5213
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 5213
Character Range: 2398497–2400632

5213                                      XANTHIUM SIBIRICUM                             A, H      The requirements specified in paragraphs (a) to (h) below apply to a medicine that contains the ingredient that is:
                                                                                                   - listed in the Register on or after 1 March 2025; or
                                                                                                   - released for supply on or after 1 March 2026.
                                                                                                   (a) Carboxyatractyloside and atractyloside are mandatory components of Xanthium sibiricum.
                                                                                                   (b) The concentration of carboxyatractyloside must not be more than 0.35% of Xanthium sibiricum.
                                                                                                   (c) The concentration of atractyloside must not be more than 0.3% of Xanthium sibiricum.
                                                                                                   (d) The route of administration for medicines that contain Xanthium sibiricum must be limited to oral.
                                                                                                   (e) The plant part must be limited to fruit that is dried, cooked and had the spines removed.
                                                                                                   (f) The plant preparation must be limited to dry, powder, and extraction preparations with water as the only solvent.
                                                                                                   (g) The maximum recommended daily dose of the medicine must not provide more than 10 g of Xanthium sibiricum.
                                                                                                   (h) The medicine must not be directed for use in children, those who are pregnant, likely to become pregnant, or lactating.