Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p41
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 41/191)
Character Range: 9927430–9939207

Authority Code 5634
                                                                                                                                                                                                                               Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; or
                                                                                                                                                                                                                               Patient must have significant bronchiectasis on chest high resolution computed tomography scan; or
                                                                                                                                                                                                                               Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; or
                                                                                                                                                                                                                               Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy;
                                                                                                                                                                                                                               Patient must be less than 5 years of age.
                                                                                                                                                                                                                               Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
                                                                                                                                                                                                                               Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.
C5635               P5635          CN5635           Dornase alfa                                                                                                                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 5635
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND
                                                                                                                                                                                                                               Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
                                                                                                                                                                                                                               Patient must be 5 years of age or older.
                                                                                                                                                                                                                               Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.
C5636               P5636          CN5636           Vancomycin                                                                                                                                                                 Antibiotic associated pseudomembranous colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                                                                               The condition must be due to Clostridium difficile; AND
                                                                                                                                                                                                                               Patient must have an intolerance to metronidazole.
C5637               P5637          CN5637           Azithromycin                                                                                                                                                               Trachoma

C5638               P5638          CN5638           Clarithromycin                                                                                                                                                             Bordetella pertussis

C5640               P5640          CN5640           Bisacodyl                                                                                                                                                                  Constipation
                                                                                                                                                                                                                               Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function.
                                                    Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

C5648               P5648          CN5648           Methotrexate                                                                                                                                                               Patients requiring doses greater than 20 mg per week

C5649               P5649          CN5649           Medroxyprogesterone                                                                                                                                                        Endometrial cancer

C5650               P5650          CN5650           Desvenlafaxine                                                                                                                                                             Major depressive disorders

                                                    Duloxetine

                                                    Mirtazapine

                                                    Moclobemide

                                                    Reboxetine

                                                    Venlafaxine

C5653               P5653          CN5653           Mycophenolic acid                                                                                                                                                          Management of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 5653
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                                                                                                                                                                                               Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit.
C5659               P5659          CN5659           Praziquantel                                                                                                                                                               Schistosomiasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority