Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p68
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 68/191)
Character Range: 10273332–10286346

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 days 2 and 3 of any chemotherapy cycle.
C6448               P6448          CN6448           Deferiprone                                                                                                                                                                Iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 6448
                                                                                                                                                                                                                               Patient must have thalassaemia major; AND
                                                                                                                                                                                                                               Patient must be unable to take desferrioxamine therapy.
C6453               P6453          CN6453           Terbinafine                                                                                                                                                                Dermatophyte infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must have failed to respond to topical treatment; AND
                                                                                                                                                                                                                               Patient must have failed to respond to griseofulvin;
                                                                                                                                                                                                                               Patient must be 18 years of age or less.
C6463               P6463          CN6463           Naproxen                                                                                                                                                                   Chronic arthropathies (including osteoarthritis)
                                                                                                                                                                                                                               The condition must have an inflammatory component.
C6464               P6464          CN6464           Aprepitant                                                                                                                                                                 Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 6464
                                                                                                                                                                                                                               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 days 2 and 3 of any chemotherapy cycle.
C6471               P6471          CN6471           Naproxen                                                                                                                                                                   Bone pain
                                                                                                                                                                                                                               The condition must be due to malignant disease.
C6475               P6475          CN6475           Liothyronine                                                                                                                                                               Hypothyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 6475
                                                                                                                                                                                                                               The condition must be severe hypothyroidism; AND
                                                                                                                                                                                                                               The treatment must be for initiation of therapy only.
C6517               P6517          CN6517           Nafarelin                                                                                                                                                                  Endometriosis
                                                                                                                                                                                                                               Subsequent treatment, for up to 6 months
                                                                                                                                                                                                                               The condition must be visually proven; AND
                                                                                                                                                                                                                               The treatment must not be within 2 years of the end of the previous course of treatment with this drug; AND
                                                                                                                                                                                                                               Patient must have had a recent bone density assessment.
                                                                                                                                                                                                                               The date of the bone density assessment must be recorded in the patient's medical records.
C6524               P6524          CN6524           Denosumab                                                                                                                                                                  Established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 6524
                                                                                                                                                                                                                               Patient must have fracture due to minimal trauma; AND
                                                                                                                                                                                                                               Patient must not receive concomitant