Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p61
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 61/476)
Character Range: 1157179–1173157

of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 5 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4.
Dolutegravir                                                           C4454                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures   Streamlined Authority Code 4454
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
                                                                       C4512                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naïve; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
Dolutegravir with abacavir and lamivudine                              C9981                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 9981
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must be antiretroviral treatment naive.
                                                                       C10116                                                               HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 10116
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection.
Dolutegravir with lamivudine                                           C9987                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 9987
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must be antiretroviral treatment naive; AND
                                                                                                                                            Patient must not have suspected resistance to either antiretroviral component.
                                                                       C11066                                                               HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 11066
                                                                                                                                            Continuing or change of treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection.
Dolutegravir with rilpivirine                                          C8214                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 8214
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                       C8226                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 8226
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy with this drug for this condition; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised therapy for this condition.
Dornase alfa                                                           C5634                                                                Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 5634
                                                                                                                                            Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
                                                                                                                                            Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
                                                                                                                                            Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non‑responsive to conventional medicines; OR
                                                                                                                                            Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy.
                                                                                                                                            Patient must be less than 5 years of age.
                                                                                                                                            Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in