Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p6
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 6/191)
Character Range: 9515173–9523969

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
                                                                                                                                                                                                                               Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides);
                                                    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

C4313               P4313          CN4313           Darunavir                                                                                                                                                                  Human immunodeficiency virus (HIV) infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 4313
                                                                                                                                                                                                                               The treatment must be in addition to optimised background therapy; AND
                                                                                                                                                                                                                               The treatment must be in combination with other antiretroviral agents; AND
                                                                                                                                                                                                                               The treatment must be co-administered with 100 mg ritonavir; AND
                                                                                                                                                                                                                               Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND
                                                                                                                                                                                                                               Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing.
                                                                                                                                                                                                                               Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.
C4319               P4319          CN4319           Ivermectin                                                                                                                                                                 Onchocerciasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 4319

C4323               P4323          CN4323           Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids                                                                     Cows' milk protein enteropathy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           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; AND
                                                    Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids                                                                                      Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula;
                                                                                                                                                                                                                               Patient must be up to 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

C4328               P4328          CN4328           Ivermectin                                                                                                                                                                 Strongyloidiasis