Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p80
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 80/191)
Character Range: 10414491–10427816

2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
                                                                                                                                                                                                                               Patient must have evidence of chronic liver injury determined by:
                                                                                                                                                                                                                                (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
C6995               P6995          CN6995           Chorionic gonadotrophin                                                                                                                                                    Hypogonadism or delayed puberty
                                                                                                                                                                                                                               Patient must be male;
                                                                                                                                                                                                                               Patient must be aged 16 years or older;
                                                                                                                                                                                                                               Patient must show clinical evidence of the condition; AND
                                                                                                                                                                                                                               The treatment must not extend beyond 6 months.
C6998               P6998          CN6998           Tenofovir                                                                                                                                                                  HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 6998
                                                                                                                                                                                                                               Initial
                                                                                                                                                                                                                               Patient must be antiretroviral treatment naive; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents.
C7025               P7025          CN7025           Lanreotide                                                                                                                                                                 Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 7025
                                                                                                                                                                                                                               The condition must be active; AND
                                                                                                                                                                                                                               Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
                                                                                                                                                                                                                               The treatment must be after failure of other therapy including dopamine agonists; or
                                                                                                                                                                                                                               The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
                                                                                                                                                                                                                               The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
                                                                                                                                                                                                                               The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
                                                                                                                                                                                                                               The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
                                                                                                                                                                                                                               The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
                                                                                                                                                                                                                               In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
C7134               P7134          CN7134           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 7134
                                                                                                                                                                                                                               Patient must have failed to respond to treatment with oral antispastic agents; or
                                                                                                                                                                                                                               Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
                                                                                                                                                                                                                               Patient must have chronic spasticity due to multiple sclerosis.
C7148               P7148          CN7148           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 7148
                                                                                                                                                                                                                               Patient must have failed to respond to treatment with oral antispastic agents; or
                                                                                                                                                                                                                               Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
                                                                                                                                                                                                                               Patient must have chronic spasticity due to spinal cord disease.
C7152               P7152          CN7152           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 7152
                                                                                                                                                                                                                               Patient must have failed to respond to treatment with oral antispastic agents; or
                                                                                                                                                                                                                               Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
                                                                                                                                                                                                                               Patient