Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1661
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1661
Character Range: 803707–805694

1661                                      CYCLOCARYA PALIURUS LEAF EXTRACT DRY                                                             A         Only to be used in a medicine where Infinitus (China) Company Ltd (Client ID 81208), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 25 October 2025.
                                                                                                                                                     The route of administration for medicines that contain Cyclocarya paliurus leaf extract dry must be limited to oral.
                                                                                                                                                     The maximum recommended daily dose of the medicine must not provide more than 2 g of Cyclocarya paliurus leaf extract dry.
                                                                                                                                                     The recommend duration of use for a medicine containing Cyclocarya paliurus leaf extract dry must be limited to 12 weeks or less.
                                                                                                                                                     The following warning statements (or words to the same effect) are required on the medicine label:
                                                                                                                                                     - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and
                                                                                                                                                     - (ADULT) 'Adults only'.