Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p14
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 14/191)
Character Range: 9594016–9608663

therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection.  or
                                                                                                                                                                                                                               Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.
C4504               P4504          CN4504           Denosumab                                                                                                                                                                  Giant cell tumour of bone                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 4504
                                                                                                                                                                                                                               Patient must be one in whom surgical resection is not feasible; or
                                                                                                                                                                                                                               Patient must be one in whom surgical resection is possible but surgery would result in significant morbidity;
                                                                                                                                                                                                                               Patient must be an adult.  or
                                                                                                                                                                                                                               Patient must be a skeletally mature adolescent.
C4510               P4510          CN4510           Adefovir                                                                                                                                                                   Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 4510
                                                                                                                                                                                                                               Patient must have cirrhosis; AND
                                                                                                                                                                                                                               Patient must have failed antihepadnaviral therapy; AND
                                                                                                                                                                                                                               Patient must have detectable HBV DNA.
                                                                                                                                                                                                                               Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
C4512               P4512          CN4512           Abacavir                                                                                                                                                                   HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 4512
                                                                                                                                                                                                                               Initial
                                                    Atazanavir                                                                                                                                                                 Patient must be antiretroviral treatment naive; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents.
                                                    Atazanavir with cobicistat

                                                    Dolutegravir

                                                    Emtricitabine with tenofovir alafenamide

                                                    Lamivudine

                                                    Lamivudine with zidovudine

                                                    Lopinavir with ritonavir

                                                    Nevirapine

                                                    Raltegravir

                                                    Rilpivirine

                                                    Ritonavir

                                                    Zidovudine

C4513               P4513          CN4513           Tobramycin                                                                                                                                                                 Proven Pseudomonas aeruginosa infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 4513
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have cystic fibrosis; AND
                                                                                                                                                                                                                               Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND
                                                                                                                                                                                                                               Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient's family (in the case of paediatric patients) and the treating physician(s);
                                                                                                                                                                                                                               Patient must be 6 years of age or older.
C4514               P4514          CN4514           Doxycycline                                                                                                                                                                Pelvic inflammatory disease

C4516               P4516          CN4516           Aclidinium                                                                                                                                                                 Chronic obstructive pulmonary disease (COPD)

                                                    Glycopyrronium

                                                    Umeclidinium

C4522               P4522          CN4522           Bictegravir with emtricitabine with tenofovir alafenamide                                                                                                                  HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 4522
                                                                                                                                                                                                                               Initial
                                                    Emtricitabine with rilpivirine with tenofovir alafenamide                                                                                                                  Patient must be antiretroviral treatment naive.

                                                    Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat

                                                    Tenofovir with emtricitabine and efavirenz

C4526               P4526          CN4526           Nevirapine                                                                                                                                                                 HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 4526
                                                                                                                                                                                                                               Initial
                                                                                                                                                                                                                               Patient must have been stabilised on nevirapine immediate release; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents.
C4527               P4527          CN4527           Abacavir with lamivudine                                                                                                                                                   HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required