Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p49
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 49/51)
Character Range: 181705–187737

qualify under the Continuing treatment criteria.
                                                Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.
C16356  P16356  CN16356  Inclisiran             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16356
                                                Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication
                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.

[123] Schedule 5, entries for Acarbose
substitute:
Acarbose  GRP-29491  Tablet 50 mg          Oral  Acarbose Viatris
                                                 GLYBOSAY
Acarbose  GRP-29491  Tablet 50 mg (S19A)   Oral  Acarbose 50 mg tablets (Morningside, UK)
Acarbose  GRP-29496  Tablet 100 mg         Oral  Acarbose Viatris
                                                 GLYBOSAY
Acarbose  GRP-29496  Tablet 100 mg (S19A)  Oral  Acarbose 100 mg tablets (Morningside, UK)

[124] Schedule 5, entry for Adalimumab [GRP-29151]
insert in the column headed "Brand" after entry for the Brand "Humira": Hyrimoz
[125] Schedule 5, omit entries for Amoxicillin with clavulanic acid [GRP-29087]
[126] Schedule 5, omit entries for Azithromycin [GRP-29088]
[127] Schedule 5, omit entry for Betaxolol
[128] Schedule 5, entry for Dutasteride with tamsulosin
insert in the column headed "Brand" after entry for the Brand "Dutasteride/Tamsulosin Lupin 500/400": Dutasteride/Tamsulosin Sandoz 500/400
[129] Schedule 5, entries for Enoxaparin
substitute:
Enoxaparin  GRP-22367  Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe    Injection  Clexane Safety-Lock
                                                                                                                                    Exarane
                                                                                                                                    Exarane Safety-Lock
Enoxaparin  GRP-22371  Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe    Injection  Clexane Safety-Lock
                                                                                                                                    Exarane
                                                                                                                                    Exarane Safety-Lock
Enoxaparin  GRP-22357  Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe    Injection  Clexane Safety-Lock
                                                                                                                                    Exarane
                                                                                                                                    Exarane Safety-Lock
Enoxaparin  GRP-22378  Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe    Injection  Clexane Safety-Lock
                                                                                                                                    Exarane
                                                                                                                                    Exarane Safety-Lock
Enoxaparin  GRP-22387  Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe    Injection  Clexane Safety-Lock
                                                                                                                                    Exarane
                                                                                                                                    Exarane Safety-Lock
Enoxaparin  GRP-28012  Injection containing enoxaparin sodium 120 mg (12,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe  Injection  Clexane Forte Safety-Lock
                                                                                                                                    Exarane Forte
                                                                                                                                    Exarane Forte Safety-Lock
Enoxaparin  GRP-28013  Injection containing enoxaparin sodium 150 mg (15,000 I.U. anti-Xa) in