Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p65
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 65/191)
Character Range: 10237948–10249723

pulmonary disease (COPD)

C6367               P6367          CN6367           Salbutamol                                                                                                                                                                 Bronchospasm
                                                                                                                                                                                                                               Patient must be unable to achieve co-ordinated use of other metered dose inhalers containing this drug.
C6368               P6368          CN6368           Naproxen                                                                                                                                                                   Chronic arthropathies (including osteoarthritis)
                                                                                                                                                                                                                               The condition must have an inflammatory component.
C6369               P6369          CN6369           Octreotide                                                                                                                                                                 Vasoactive intestinal peptide secreting tumour (VIPoma)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 6369
                                                                                                                                                                                                                               The condition must be causing intractable symptoms; AND
                                                                                                                                                                                                                               Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
                                                                                                                                                                                                                               Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
                                                                                                                                                                                                                               The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
                                                                                                                                                                                                                               Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C6370               P6370          CN6370           Aprepitant                                                                                                                                                                 Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 6370
                                                                                                                                                                                                                               The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
                                                                                                                                                                                                                               The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
                                                                                                                                                                                                                               Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
                                                                                                                                                                                                                               No more than 1 capsule of aprepitant 165 mg will be authorised per cycle of cytotoxic chemotherapy.
                                                                                                                                                                                                                               Concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle.
C6377               P6377          CN6377           Darunavir with cobicistat                                                                                                                                                  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 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.
C6382               P6382          CN6382           Liothyronine                                                                                                                                                               Thyroid cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 6382

C6383               P6383          CN6383           Aprepitant                                                                                                                                                                 Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 6383
                                                                                                                                                                                                                               The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
                                                                                                                                                                                                                               The treatment must be in combination with a 5-hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
                                                                                                                                                                                                                               Patient must be scheduled to