Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p38
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 38/191)
Character Range: 9892035–9904121

media                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must be less than 18 years of age;
                                                                                                                                                                                                                               Patient must have a grommet in situ.
C5540               P5540          CN5540           Mycobacterium bovis (Bacillus Calmette and Guerin (BCG)) Danish 1331 strain                                                                                                Primary and relapsing superficial urothelial carcinoma of the bladder

                                                    Mycobacterium bovis (Bacillus Calmette and Guerin), Tice strain

C5541               P5541          CN5541           Triglycerides - medium chain, formula                                                                                                                                      Dietary management of conditions requiring a source of medium chain triglycerides
                                                                                                                                                                                                                               Patient must have fat malabsorption due to liver disease.  or
                                                                                                                                                                                                                               Patient must have fat malabsorption due to short gut syndrome.  or
                                                                                                                                                                                                                               Patient must have fat malabsorption due to cystic fibrosis.  or
                                                                                                                                                                                                                               Patient must have fat malabsorption due to gastrointestinal disorders.
C5542               P5542          CN5542           Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine                                                               Propionic acidaemia

C5551               P5551          CN5551           Ciprofloxacin                                                                                                                                                              Chronic suppurative otitis media                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must be less than 18 years of age;
                                                                                                                                                                                                                               Patient must have perforation of the tympanic membrane.
C5554               P5554          CN5554           Everolimus                                                                                                                                                                 Management of cardiac allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 5554
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                    Mycophenolic acid                                                                                                                                                          Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit.
C5559               P5559          CN5559           Amino acid formula with vitamins and minerals without methionine                                                                                                           Pyridoxine non-responsive homocystinuria
                                                                                                                                                                                                                               Patient must be an infant or a very young child.
C5560               P5560          CN5560           Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine                                                               Methylmalonic acidaemia

C5561               P5561          CN5561           Amylopectin, modified long chain                                                                                                                                           Glycogen storage disease

C5569               P5569          CN5569           Tacrolimus                                                                                                                                                                 Management of rejection in patients following organ or tissue transplantation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 5569
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit; AND
                                                                                                                                                                                                                               The treatment must include initiation, stabilisation, and review of therapy as required.
C5571               P5571          CN5571           Amino acid formula with fat, carbohydrate without valine, leucine and isoleucine                                                                                           Maple syrup urine disease

                                                    Amino acid formula without valine, leucine and isoleucine

                                                    Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

                                                    Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexaenoic acid

                                                    Amino acid formula with vitamins and minerals without valine, leucine, isoleucine and supplemented with arachidonic acid and docosahexaenoic acid

                                                    Isoleucine with carbohydrate

                                                    Valine with carbohydrate

C5572               P5572          CN5572           Ponatinib                                                                                                                                                                  Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must be expressing the T315I mutation; AND
                                                                                                                                                                                                                               Patient must have failed treatment with chemotherapy,