Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p5
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 5/191)
Character Range: 9505876–9515569

phenylalanine

                                                    Amino acid formula with vitamins and minerals without phenylalanine

                                                    Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid

                                                    Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine

                                                    Amino acid formula without phenylalanine

                                                    Glycomacropeptide and essential amino acids with vitamins and minerals

                                                    Glycomacropeptide formula with amino acids and low phenylalanine

                                                    Glycomacropeptide formula with amino acids, vitamins, minerals, trace elements, carbohydrate, fat and low phenylalanine

                                                    Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine

                                                    Tyrosine with carbohydrate

C4302               P4302          CN4302           Iron polymaltose complex                                                                                                                                                   Iron deficiency anaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 4302
                                                                                                                                                                                                                               Patient must be undergoing chronic haemodialysis.
                                                    Iron sucrose

C4305               P4305          CN4305           Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids                                                                     Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 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; 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 older than 24 months of age.
                                                                                                                                                                                                                               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

C4306               P4306          CN4306           Rifaximin                                                                                                                                                                  Prevention of hepatic encephalopathy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                                                                                                                               Must be treated by a gastroenterologist or hepatologist or in consultation with a gastroenterologist or hepatologist; AND
                                                                                                                                                                                                                               The treatment must be in combination with lactulose, if lactulose is tolerated; AND
                                                                                                                                                                                                                               Patient must have had prior episodes of hepatic encephalopathy.
C4311               P4311          CN4311           Amlodipine with valsartan and hydrochlorothiazide                                                                                                                          Hypertension
                                                                                                                                                                                                                               The treatment must not be for the initiation of anti-hypertensive therapy; AND
                                                    Olmesartan with amlodipine and hydrochlorothiazide                                                                                                                         The condition must be inadequately controlled with concomitant treatment with two of the following:
                                                                                                                                                                                                                                an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.
C4312               P4312          CN4312           Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids                                                                     Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            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