Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p56
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 56/476)
Character Range: 1096621–1108079

other neuroleptic agents.
                                                                                                                                            Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.
                                                                                                                                            The name of the consulting psychiatrist should be included in the patient's medical records.
                                                                                                                                            A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.
Darbepoetin Alfa                                                       C6294                                                                Anaemia associated with intrinsic renal disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294
                                                                                                                                            Patient must require transfusion; AND
                                                                                                                                            Patient must have a haemoglobin level of less than 100 g per L; AND
                                                                                                                                            Patient must have intrinsic renal disease, as assessed by a nephrologist.
                                                                       C9688                                                                Anaemia associated with intrinsic renal disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 9688
                                                                                                                                            Patient must require transfusion; AND
                                                                                                                                            Patient must have a haemoglobin level of less than 100 g per L; AND
                                                                                                                                            Patient must have intrinsic renal disease, as assessed by a nephrologist.
Darunavir                                                              C4313                                                                Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 4313
                                                                                                                                            The treatment must be in addition to optimised background therapy, AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents, AND
                                                                                                                                            The treatment must be co‑administered with 100 mg ritonavir, AND
                                                                                                                                            Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen, AND
                                                                                                                                            Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing.
                                                                                                                                            Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity.
                                                                       C5094                                                                Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 5094
                                                                                                                                            The treatment must be in addition to optimised background therapy, AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents, AND
                                                                                                                                            The treatment must be co‑administered with 100 mg ritonavir twice daily, AND
                                                                                                                                            Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen.
                                                                                                                                            Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity.
Darunavir with cobicistat                                              C6377                                                                Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 6377
                                                                                                                                            The treatment must be in addition to optimised background therapy; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents; AND
                                                                                                                                            The treatment must not be in combination with ritonavir; AND
                                                                                                                                            Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen.
                                                                                                                                            Virological failure is defined