Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3578
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3578
Character Range: 1677745–1679715

3578                                      OMEGA-3-ACID ETHYL ESTERS 60                                                                  A         Docosahexaenoic acid, docosapentaenoic acid and eicosapentaenoic acid are mandatory components of omega-3-acid ethyl esters 60.
                                                                                                                                                  Only permitted for use in medicines that are for oral routes of administration.
                                                                                                                                                  The maximum recommended daily dose of the medicine must not provide more than 3750 milligrams of docosahexaenoic acid, docosapentaenoic acid and eicosapentaenoic acid combined.
                                                                                                                                                  The following warning statements are required on the medicine label:
                                                                                                                                                  - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect);
                                                                                                                                                  - (ACOAG) 'Individuals taking anticoagulants should seek medical advice before taking this product' (or words to that effect);
                                                                                                                                                  - (CHILD3) 'Use in children under 12 years is not recommended';
                                                                                                                                                  - (FOOD) 'To be taken with food' (or words to that effect).