Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p311
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 311/476)
Character Range: 2827572–2838485

to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                            At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.
Pegfilgrastim                                                          C7822                                                                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
                                                                                                                                            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.
                                                                       C7843                                                                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
                                                                                                                                            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.
                                                                       C9235                                                                Chemotherapy‑induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 9235
                                                                                                                                            Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                            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.
                                                                       C9303                                                                Chemotherapy‑induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 9303
                                                                                                                                            Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                            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.
Peginterferon                                                          C5004                                                                Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 5004
alfa‑2a                                                                                                                                     Must be treated in an accredited treatment centre.
                                                                                                                                            Patient must be aged 18 years or older; AND
                                                                                                                                            Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child‑bearing age.
                                                                                                                                            Patient must have compensated liver disease; AND
                                                                                                                                            Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
                                                                                                                                            Patient must have a contraindication to ribavirin; AND
                                                                                                                                            The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
                                                                                                                                            The treatment must be limited to a maximum duration of 48 weeks.
                                                                                                                                            Evidence