Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p67
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 67/191)
Character Range: 10260319–10274003

CN6409           Leuprorelin                                                                                                                                                                Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate

                                                    Triptorelin

C6410               P6410          CN6410           Liothyronine                                                                                                                                                               Hypothyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 6410
                                                                                                                                                                                                                               The treatment must be for replacement therapy; AND
                                                                                                                                                                                                                               Patient must have documented intolerance to levothyroxine sodium.  or
                                                                                                                                                                                                                               Patient must have documented resistance to levothyroxine sodium.
C6412               P6412          CN6412           Terbinafine                                                                                                                                                                Fungal or yeast infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 6412
                                                                                                                                                                                                                               The condition must be fungal; or
                                                                                                                                                                                                                               The condition must be due to yeast;
                                                                                                                                                                                                                               Patient must be 18 years of age or less.
C6413               P6413          CN6413           Darunavir with cobicistat                                                                                                                                                  Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 6413
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must be antiretroviral treatment naive; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents; AND
                                                                                                                                                                                                                               The treatment must not be in combination with ritonavir.
C6421               P6421          CN6421           Tamoxifen                                                                                                                                                                  Reduction of breast cancer risk
                                                                                                                                                                                                                               Patient must have a moderate or high risk of developing breast cancer; AND
                                                                                                                                                                                                                               The treatment must not exceed a dose of 20 mg per day; AND
                                                                                                                                                                                                                               The treatment must not exceed a lifetime maximum of 5 years for this condition.
C6428               P6428          CN6428           Darunavir with cobicistat                                                                                                                                                  Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 6428
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy for HIV infection; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents; AND
                                                                                                                                                                                                                               The treatment must not be in combination with ritonavir.
C6434               P6434          CN6434           Miconazole                                                                                                                                                                 Fungal or yeast infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 6434
                                                                                                                                                                                                                               Patient must be an Aboriginal or a Torres Strait Islander person.
                                                    Terbinafine

C6444               P6444          CN6444           Aprepitant                                                                                                                                                                 Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 6444
                                                                                                                                                                                                                               The condition must be associated with moderately emetogenic 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 have had a prior episode of chemotherapy induced nausea or vomiting; AND
                                                                                                                                                                                                                               Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following intravenous chemotherapy agents:
                                                                                                                                                                                                                                arsenic trioxide; azacitidine; cyclophosphamide at a dose of less than 1500 mg per square metre per day; cytarabine at a dose of greater than 1 g per square metre per day; dactinomycin; daunorubicin; doxorubicin; epirubicin; fotemustine; idarubicin; ifosfamide; irinotecan; melphalan; methotrexate at a dose of 250 mg to 1 g per square metre; raltitrexed.
                                                                                                                                                                                                                               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