Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p13
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 13/191)
Character Range: 9581546–9594475

long chain with glucose polymer

C4454               P4454          CN4454           Abacavir                                                                                                                                                                   HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 4454
                                                                                                                                                                                                                               Continuing
                                                    Atazanavir                                                                                                                                                                 Patient must have previously received PBS-subsidised therapy for HIV infection; 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

C4456               P4456          CN4456           Tobramycin                                                                                                                                                                 Proven Pseudomonas aeruginosa infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 4456
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have cystic fibrosis; AND
                                                                                                                                                                                                                               Patient must have been assessed for bronchial hyperresponsiveness as per the TGA-approved Product Information, with a negative test result; AND
                                                                                                                                                                                                                               Patient must be participating in a four week trial of tobramycin inhalation powder and will be assessed for ability to tolerate the dry powder formulation in order to qualify for continued PBS-subsidised therapy. The trial commencement date must be documented in the patient's medical records;
                                                                                                                                                                                                                               Patient must be 6 years of age or older.
C4470               P4470          CN4470           Bictegravir with emtricitabine with tenofovir alafenamide                                                                                                                  HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 4470
                                                                                                                                                                                                                               Continuing
                                                    Emtricitabine with rilpivirine with tenofovir alafenamide                                                                                                                  Patient must have previously received PBS-subsidised therapy for HIV infection.

                                                    Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat

                                                    Tenofovir with emtricitabine and efavirenz

C4473               P4473          CN4473           Afatinib                                                                                                                                                                   Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                    Erlotinib                                                                                                                                                                  The treatment must be as monotherapy; AND
                                                                                                                                                                                                                               The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
                                                    Gefitinib                                                                                                                                                                  Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); or
                                                                                                                                                                                                                               Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND
                                                                                                                                                                                                                               Patient must have a WHO performance status of 2 or less;
                                                                                                                                                                                                                               Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.
C4475               P4475          CN4475           Doxycycline                                                                                                                                                                Chronic bronchitis
                                                                                                                                                                                                                               Patient must be aged 8 years or older.
C4485               P4485          CN4485           Doxycycline                                                                                                                                                                Urethritis

C4490               P4490          CN4490           Adefovir                                                                                                                                                                   Chronic hepatitis B infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 4490
                                                                                                                                                                                                                               Patient must not have cirrhosis; AND
                                                                                                                                                                                                                               Patient must have failed antihepadnaviral therapy; AND
                                                                                                                                                                                                                               Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral 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