Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p448
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 448/476)
Character Range: 3718889–3729429

is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                            A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised
                                                                                                                                            Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
                                                                                                                                            Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
                                                                       C14801                                                               Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                            Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
                                                                                                                                            Must be treated by a gastroenterologist (code 87); OR
                                                                                                                                            Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
                                                                                                                                            Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]
Valaciclovir                                                           C5975                                                                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.
                                                                       C9267                                                                Cytomegalovirus infection and disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 9267
                                                                                                                                            Prophylaxis
                                                                                                                                            Patient must have undergone a renal transplant; AND
                                                                                                                                            Patient must be at risk of cytomegalovirus disease.
Valganciclovir                                                         C4980                                                                Cytomegalovirus retinitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 4980
                                                                                                                                            Patient must have HIV infection.
                                                                       C15782                                                               Cytomegalovirus infection and disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 15782
                                                                                                                                            Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.
                                                                       C15784                                                               Cytomegalovirus infection