Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p89
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 89/191)
Character Range: 10517626–10530412

by magnetic resonance imaging of the brain and/or spinal cord; or
                                                                                                                                                                                                                               The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                                                                               Patient must be ambulatory (without assistance or support); AND
                                                                                                                                                                                                                               Must be treated by a neurologist.
                                                                                                                                                                                                                               Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C7781               P7781          CN7781           Montelukast                                                                                                                                                                Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 7781
                                                                                                                                                                                                                               Prevention of condition
                                                                                                                                                                                                                               The condition must be exercise-induced; AND
                                                                                                                                                                                                                               The treatment must be as an alternative to adding salmeterol xinafoate; or
                                                                                                                                                                                                                               The treatment must be an alternative to adding formoterol fumarate; AND
                                                                                                                                                                                                                               The condition must be otherwise well controlled while receiving optimal dose inhaled corticosteroid; AND
                                                                                                                                                                                                                               Patient must require short-acting beta-2 agonist 3 or more times per week for prevention or relief of residual exercise-related symptoms;
                                                                                                                                                                                                                               Patient must be aged 6 to 14 years inclusive.
C7789               P7789          CN7789           Perampanel                                                                                                                                                                 Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 7789
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition;
                                                                                                                                                                                                                               Patient must be aged 12 years or older.
C7798               P7798          CN7798           Aclidinium with formoterol                                                                                                                                                 Chronic obstructive pulmonary disease (COPD)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 7798
                                                                                                                                                                                                                               Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA).  or
                                                    Indacaterol with glycopyrronium                                                                                                                                            Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA).  or
                                                                                                                                                                                                                               Patient must have been stabilised on a combination of a LAMA and a LABA.
                                                    Tiotropium with olodaterol

                                                    Umeclidinium with vilanterol

C7815               P7815          CN7815           Perampanel                                                                                                                                                                 Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 7815
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Must be treated by a neurologist; AND
                                                                                                                                                                                                                               The condition must have failed to be controlled satisfactorily by at least two anti-epileptic drugs; AND
                                                                                                                                                                                                                               The treatment must be in combination with at least one PBS-subsidised anti-epileptic drug; AND
                                                                                                                                                                                                                               The treatment must be for dose titration purposes;
                                                                                                                                                                                                                               Patient must be aged 12 years or older.
C7822               P7822          CN7822           Filgrastim                                                                                                                                                                 Chemotherapy-induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 7822
                                                                                                                                                                                                                               Patient must be receiving chemotherapy with