Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p51
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 51/191)
Character Range: 10056812–10071324

fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides                                                               Eosinophilic oesophagitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                    Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides                                                       Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND
                                                                                                                                                                                                                               Patient must have responded to an initial course of PBS-subsidised treatment;
                                                                                                                                                                                                                               Patient must be 18 years of age or less.
                                                                                                                                                                                                                               Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.
C5975               P5975          CN5975           Valaciclovir                                                                                                                                                               Cytomegalovirus infection and disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 5975
                                                                                                                                                                                                                               Prophylaxis
                                                                                                                                                                                                                               Patient must have undergone a renal transplant; AND
                                                                                                                                                                                                                               Patient must be at risk of cytomegalovirus disease.
C5981               P5981          CN5981           Atovaquone with proguanil                                                                                                                                                  Confirmed or suspected Plasmodium falciparum malaria
                                                                                                                                                                                                                               Patient must be aged 3 years or older;
                                                                                                                                                                                                                               The treatment must be used where quinine containing regimens are inappropriate.
C5984               P5984          CN5984           Citrulline                                                                                                                                                                 Urea cycle disorders
                                                                                                                                                                                                                               The treatment must be for preventing low plasma arginine levels.  or
                                                                                                                                                                                                                               The treatment must be for preventing low citrulline levels.
C5986               P5986          CN5986           Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine                                                               Propionic acidaemia

C5989               P5989          CN5989           Fluconazole                                                                                                                                                                Oesophageal candidiasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 5989
                                                                                                                                                                                                                               Patient must be immunosuppressed.
C5995               P5995          CN5995           Minocycline                                                                                                                                                                Severe acne
                                                                                                                                                                                                                               The condition must not be responding to other tetracyclines.
C5997               P5997          CN5997           Arsenic                                                                                                                                                                    Acute promyelocytic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 5997
                                                                                                                                                                                                                               The condition must be characterised by the presence of the t(15:
                                                                                                                                                                                                                                17) translocation or PML/RAR-alpha fusion gene transcript.
C5999               P5999          CN5999           Artemether with lumefantrine                                                                                                                                               Confirmed or suspected Plasmodium falciparum malaria

C6007               P6007          CN6007           Amino acid formula with vitamins and minerals without lysine and low in tryptophan                                                                                         Proven glutaric aciduria type 1

C6013               P6013          CN6013           Dabrafenib                                                                                                                                                                 Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 6013
                                                                                                                                                                                                                               Continuing treatment
                                                    Encorafenib                                                                                                                                                                Patient must have previously been issued with an authority prescription for this drug; AND
                                                                                                                                                                                                                               Patient must have stable or responding disease.
                                                    Vemurafenib

C6018               P6018          CN6018           Arsenic                                                                                                                                                                    Acute promyelocytic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 6018
                                                                                                                                                                                                                               Induction and consolidation treatment
                                                                                                                                                                                                                               The condition must be characterised by the presence of the t(15:
                                                                                                                                                                                                                                17) translocation or PML/RAR-alpha fusion gene transcript.
C6023               P6023          CN6023           Fluconazole                                                                                                                                                                Oropharyngeal candidiasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 6023
                                                                                                                                                                                                                               Patient must be immunosuppressed.
C6026