Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p9
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 9/191)
Character Range: 9539220–9550250

the age of 24 months.
                                                    Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides                                                       The name of the specialist and the date of birth of the patient must be included in the authority application.

                                                    Amino acids-synthetic, formula

C4351               P4351          CN4351           Everolimus                                                                                                                                                                 Tuberous sclerosis complex (TSC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; or
                                                                                                                                                                                                                               The condition must be visceral tumours associated with TSC; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must not be a candidate for curative surgical resection.
C4352               P4352          CN4352           Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids                                                                     Severe cows' milk protein enteropathy with failure to thrive                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment for up to 6 months
                                                    Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides                                                               Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; AND
                                                                                                                                                                                                                               The condition must not be isolated infant colic or reflux;
                                                    Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids                                                                                      Patient must be up to the age of 24 months.
                                                                                                                                                                                                                               The name of the specialist and the date of birth of the patient must be included in the authority application.
                                                    Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

                                                    Amino acids-synthetic, formula

C4359               P4359          CN4359           Apixaban                                                                                                                                                                   Prevention of venous thromboembolism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 4359
                                                                                                                                                                                                                               Patient must be undergoing total hip replacement; AND
                                                                                                                                                                                                                               Patient must require up to 10 days supply to complete a course of treatment.
C4361               P4361          CN4361           Valsartan with hydrochlorothiazide                                                                                                                                         Hypertension
                                                                                                                                                                                                                               The treatment must not be for the initiation of anti-hypertensive therapy; AND
                                                                                                                                                                                                                               The condition must be inadequately controlled with an angiotensin II antagonist.  or
                                                                                                                                                                                                                               The condition must be inadequately controlled with a thiazide diuretic.
C4368               P4368          CN4368           Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids                                                                     Eosinophilic oesophagitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment for up to 3 months
                                                    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 require an amino acid based formula as a component of a dietary elimination program;
                                                    Amino acids-synthetic, formula                                                                                                                                             Patient must be 18 years of age or less.
                                                                                                                                                                                                                               Treatment with oral steroids should not be commenced during the period of initial treatment.
                                                                                                                                                                                                                               Eosinophilic oesophagitis is demonstrated by the following criteria
                                                                                                                                                                                                                               (i) Chronic symptoms of reflux that persisted