Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p312
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 312/312)
Character Range: 17467822–17473195

where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens.
C16285              P16285         CN16285          Saxagliptin with dapagliflozin                                         Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           The treatment must be in combination with at least metformin; AND
                                                                                                                           The condition must be inadequately responsive to dual therapy consisting of metformin with either: a DDP-4 inhibitor, an SGLT2 inhibitor; AND
                                                                                                                           Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor, another DPP4 inhibitor.
C16288              P16288         CN16288          Hydroxocobalamin                                                       Pernicious anaemia
                                                                                                                           Patient must identify as Aboriginal or Torres Strait Islander;
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.
C16289              P16289         CN16289          Hydroxocobalamin                                                       Proven vitamin B12 deficiencies other than pernicious anaemia
                                                                                                                           Patient must identify as Aboriginal or Torres Strait Islander;
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.
C16290              P16290         CN16290          Saxagliptin with dapagliflozin                                         Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           The treatment must be in combination with at least metformin; AND
                                                                                                                           The condition must be inadequately responsive to dual therapy consisting of metformin with either: a DDP-4 inhibitor, an SGLT2 inhibitor; AND
                                                                                                                           Patient must not be undergoing concomitant PBS-subsidised treatment with any of: a GLP-1 receptor agonist, another SGLT2 inhibitor, another DPP4 inhibitor.

Part 2—Variation rules