Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p16
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 16/381)
Character Range: 11540393–11557095

P10375         CN10375          Levodopa with carbidopa                                                                                         Advanced Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 10375
                                                                                                                                                                    Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
                                                                                                                                                                    The treatment must be commenced in a hospital-based movement disorder clinic; AND
                                                                                                                                                                    Patient must require continuous administration of levodopa without an overnight break.  or
                                                                                                                                                                    Patient must require a total daily dose of more than 2000 mg of levodopa.
C10386              P10386         CN10386          Levodopa with carbidopa                                                                                         Advanced Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 10386
                                                                                                                                                                    Maintenance therapy
                                                                                                                                                                    Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
                                                                                                                                                                    Patient must have been commenced on treatment in a hospital-based movement disorder clinic; AND
                                                                                                                                                                    Patient must require continuous administration of levodopa without an overnight break.  or
                                                                                                                                                                    Patient must require a total daily dose of more than 2000 mg of levodopa.
C10388              P10388         CN10388          Evolocumab                                                                                                      Familial homozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 10388
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be in conjunction with dietary therapy and exercise.
C10390              P10390         CN10390          Sapropterin                                                                                                     Hyperphenylalaninaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated by a metabolic physician; or
                                                                                                                                                                    Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
                                                                                                                                                                    Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition.
                                                                                                                                                                    Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.
C10391              P10391         CN10391          Sapropterin                                                                                                     Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a metabolic physician; AND
                                                                                                                                                                    Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
                                                                                                                                                                    Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.
C10402              P10402         CN10402          Amoxicillin                                                                                                     Infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 10402
                                                                                                                                                                    Patient must be a male with acute cystitis.  or
                                                                                                                                                                    Patient must have pyelonephritis.  or
                                                                                                                                                                    Patient must have a tooth avulsion.  or
                                                                                                                                                                    Patient must have salmonella enteritis.  or
                                                                                                                                                                    Patient must have community acquired pneumonia.  or
                                                                                                                                                                    Patient must have a condition requiring prolonged oral antibiotic therapy.
C10404              P10404         CN10404          Amoxicillin                                                                                                     Infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 10404
                                                                                                                                                                    Patient must have a condition requiring prolonged oral antibiotic therapy.
                                                    Roxithromycin

C10405              P10405         CN10405          Amoxicillin with clavulanic acid                                                                                Infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 10405
                                                                                                                                                                    Patient must