Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p88
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 88/312)
Character Range: 16019685–16028036

or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
                                                                                                                           A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
C15036              P15036         CN15036          Tobramycin                                                             Proven Pseudomonas aeruginosa infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 15036
                                                                                                                           Continuing treatment
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           Patient must have cystic fibrosis; AND
                                                                                                                           Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND
                                                                                                                           Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient's family (in the case of paediatric patients) and the treating physician(s);
                                                                                                                           Patient must be 6 years of age or older.
C15040              P15040         CN15040          Tobramycin                                                             Proven Pseudomonas aeruginosa infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 15040
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           Patient must have cystic fibrosis; AND
                                                                                                                           The treatment must be for management.
C15043              P15043         CN15043          Bromocriptine                                                          Pathological hyperprolactinaemia
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           Patient must be one in whom surgery is not indicated.
C15044              P15044         CN15044          Bromocriptine                                                          Pathological hyperprolactinaemia
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           Patient must be one in whom radiotherapy is not indicated.
C15047              P15047         CN15047          Dapagliflozin                                                          Chronic heart failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 15047
                                                                                                                           Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND
                                                    Empagliflozin                                                          Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; or
                                                                                                                           The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an