Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p115
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 115/476)
Character Range: 1546851–1560526

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.
                                                                       C8667                                                                Chemotherapy‑induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 8667
                                                                                                                                            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.
                                                                       C8668                                                                Mobilisation of peripheral blood progenitor cells                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 8668
                                                                                                                                            The treatment must be in a normal volunteer for use in allogeneic transplantation.
                                                                       C8669                                                                Severe congenital neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 8669
                                                                                                                                            Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND
                                                                                                                                            Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.
                                                                       C8670                                                                Severe chronic neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 8670
                                                                                                                                            Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; OR
                                                                                                                                            Patient must have neutrophil dysfunction; AND
                                                                                                                                            Patient must have experienced a life‑threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; OR
                                                                                                                                            Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.
                                                                       C8671                                                                Assisting bone marrow transplantation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 8671
                                                                                                                                            Patient must be receiving marrow‑ablative chemotherapy prior to the transplantation.
                                                                       C8672                                                                Mobilisation of peripheral blood progenitor cells                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 8672
                                                                                                                                            The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non‑myeloid malignancy who has had myeloablative or myelosuppressive therapy.
                                                                       C8673                                                                Chronic cyclical neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 8673
                                                                                                                                            Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND
                                                                                                                                            Patient must have experienced a life‑threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; OR
                                                                                                                                            Patient must