Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p90
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 90/191)
Character Range: 10528695–10542505

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 the intention of achieving a cure or a substantial remission; AND
                                                    Lipegfilgrastim                                                                                                                                                            Patient must be at greater than 20% risk of developing febrile neutropenia.  or
                                                                                                                                                                                                                               Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.
                                                    Pegfilgrastim

C7843               P7843          CN7843           Filgrastim                                                                                                                                                                 Chemotherapy-induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 7843
                                                                                                                                                                                                                               Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                    Lipegfilgrastim                                                                                                                                                            Patient must have had a prior episode of febrile neutropenia.  or
                                                                                                                                                                                                                               Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.
                                                    Pegfilgrastim

C7876               P7876          CN7876           Atomoxetine                                                                                                                                                                Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 7876
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Must be treated by a paediatrician or psychiatrist; AND
                                                                                                                                                                                                                               The condition must be or have been diagnosed according to the DSM-5 criteria; AND
                                                                                                                                                                                                                               Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; or
                                                                                                                                                                                                                               Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; or
                                                                                                                                                                                                                               Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; or
                                                                                                                                                                                                                               Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously);
                                                                                                                                                                                                                               Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.
C7890               P7890          CN7890           Atomoxetine                                                                                                                                                                Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 7890
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition.
C7927               P7927          CN7927           Quetiapine                                                                                                                                                                 Acute mania                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 7927
                                                                                                                                                                                                                               The condition must be associated with bipolar I disorder; AND
                                                                                                                                                                                                                               The treatment must be as monotherapy.
C7943               P7943          CN7943           Bendamustine                                                                                                                                                               Previously untreated stage II bulky or stage III or IV indolent non-Hodgkin's lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 7943
                                                                                                                                                                                                                               Induction treatment
                                                                                                                                                                                                                               The condition must be CD20 positive; AND
                                                                                                                                                                                                                               The condition must be previously untreated; AND
                                                                                                                                                                                                                               The condition must be symptomatic; AND
                                                                                                                                                                                                                               The treatment must be for induction treatment purposes only; AND
                                                                                                                                                                                                                               The treatment must be in combination with rituximab or obinutuzumab; AND
                                                                                                                                                                                                                               The treatment must not exceed 6 cycles (12 doses) with