Schedule 1 Amendments
[1] Schedule 1, entry for Abacavir with lamivudine in the form Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg
omit:
| | | | Abacavir/Lamivudine 600/300 APOTEX | TX | MP | C4527 C4528 | | 60 | 5 | 30 | | D(100) |
[2] Schedule 1, after entry for Abatacept in the form Powder for I.V. infusion 250 mg
insert:
Abemaciclib | Tablet 50 mg | Oral | | Verzenio | LY | MP | C10019 C10032 | | 56 | 5 | 56 | | |
| Tablet 100 mg | Oral | | Verzenio | LY | MP | C10019 C10032 | | 56 | 5 | 56 | | |
| Tablet 150 mg | Oral | | Verzenio | LY | MP | C10019 C10032 | | 56 | 5 | 56 | | |
[3] Schedule 1, entry for Alprazolam in each of the forms: Tablet 500 micrograms; and Tablet 1 mg
omit from the column headed “Responsible Person”: QA substitute: AS
[4] Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Responsible Person” for the brand “Moxiclav Duo 500/125” (all instances): QA substitute: LN
[5] Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Responsible Person” for the brand “Moxiclav Duo Forte 875/125” (all instances): QA substitute: LN
[6] Schedule 1, entry for Amphotericin B
omit from the column headed “Responsible Person”: QA substitute: AS
[7] Schedule 1, entry for Anastrozole
omit from the column headed “Responsible Person” for the brand “Anastrol”: QA substitute: AS
[8] Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium)
(a) omit:
| | | a | Atorvastatin Sandoz | SZ | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Atorvastatin Sandoz | SZ | MP | | P7598 | 30 | 11 | 30 | | |
[9] Schedule 1, entry for Atropine in the form Eye drops containing atropine sulfate monohydrate 10 mg per mL, 15 mL
omit from the column headed “Responsible Person”: QA substitute: AS
[10] Schedule 1, entry for Avelumab
(a) omit from the column headed “Circumstances”: C8856
(b) insert in numerical order in the column headed “Circumstances”: C10023
[11] Schedule 1, entry for Azacitidine
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Azacitidine-Teva | TB | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | | D(100) |
[12] Schedule 1, entry for Betamethasone in the form Cream 200 micrograms (as valerate) per g, 100 g
(a) omit from the column headed “Responsible Person” for the brand “Betnovate 1/5”: QA substitute: AS
(b) omit from the column headed “Responsible Person” for the brand “Cortival 1/5”: FM substitute: LN
[13] Schedule 1, entry for Betamethasone in the form Cream 500 micrograms (as valerate) per g, 15 g
(a) omit from the column headed “Responsible Person” for the brand “Betnovate 1/2” (all instances): QA substitute: AS
(b) omit from the column headed “Responsible Person” for the brand “Cortival 1/2” (all instances): FM substitute: LN
[14] Schedule 1, entry for Bicalutamide
omit from the column headed “Responsible Person”: QA substitute: AS
[15] Schedule 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL
omit from the column headed “Responsible Person”: QA substitute: AS
[16] Schedule 1, entry for Budesonide in the form Rectal foam 2 mg per application, 14 applications, aerosol 16.8 g, 2
omit from the column headed “Responsible Person”: OA substitute: FD
[17] Schedule 1, entry for Capecitabine in the form Tablet 500 mg
(a) omit:
| | | a | Capecitabine Apotex | TX | MP | | | 120 | 2 | 120 | | |
(b) omit from the column headed “Responsible Person” for the brand “Xelabine”: QA substitute: AS
[18] Schedule 1, entry for Chloramphenicol
omit from the column headed “Responsible Person”: QA substitute: AS
[19] Schedule 1, entry for Cladribine in the form Injection 10 mg in 5 mL
omit from the column headed “Responsible Person”: OA substitute: AS
[20] Schedule 1, entry for Cobimetinib in the form Tablet 20 mg [Maximum Quantity: 63; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C6839
(b) insert in numerical order in the column headed “Circumstances”: C10033
(c) omit from the column headed “Purposes”: P6839 substitute: P10033
[21] Schedule 1, entry for Cobimetinib in the form Tablet 20 mg [Maximum Quantity: 63; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C6839
(b) insert in numerical order in the column headed “Circumstances”: C10033
[22] Schedule 1, entry for Codeine
omit from the column headed “Responsible Person”: QA substitute: AS
[23] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg
omit from the column headed “Responsible Person” for the brand “Cyprocur 50” (all instances): QA substitute: AS
[24] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
omit from the column headed “Responsible Person” for the brand “Cyprocur 100”: QA substitute: AS
[25] Schedule 1, entry for Dexamfetamine
omit from the column headed “Responsible Person”: QA substitute: AS
[26] Schedule 1, entry for Digoxin in the form Paediatric oral solution 50 micrograms per mL, 60 mL
omit from the column headed “Responsible Person”: QA substitute: AS
[27] Schedule 1, entry for Digoxin in the form Tablet 62.5 micrograms
(a) omit from the column headed “Responsible Person”: QA substitute: AS
(b) omit from the column headed “Responsible Person”: FM substitute: LN
[28] Schedule 1, entry for Digoxin in the form Tablet 250 micrograms
(a) omit from the column headed “Responsible Person”: QA substitute: AS
(b) omit from the column headed “Responsible Person”: FM substitute: LN
[29] Schedule 1, entry for Dorzolamide
omit from the column headed “Responsible Person”: QA substitute: AS
[30] Schedule 1, entry for Dorzolamide with timolol
omit from the column headed “Responsible Person”: QA substitute: AS
[31] Schedule 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | EzSimva GH 10/10 | GQ | MP NP | C7958 | | 30 | 5 | 30 | | |
[32] Schedule 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | EzSimva GH 10/20 | GQ | MP NP | C7958 | | 30 | 5 | 30 | | |
[33] Schedule 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | EzSimva GH 10/40 | GQ | MP NP | C7957 | | 30 | 5 | 30 | | |
[34] Schedule 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-80 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | EzSimva GH 10/80 | GQ | MP NP | C7957 | | 30 | 5 | 30 | | |
[35] Schedule 1, entry for Fluconazole
omit:
| Solution for I.V. infusion 100 mg in 50 mL | Injection | | Fluconazole Sandoz | SZ | MP NP | C5978 C5989 C6002 C6023 C6030 C7898 | | 7 | 0 | 1 | | |
[36] Schedule 1, entry for Fludrocortisone
omit from the column headed “Responsible Person”: QA substitute: AS
[37] Schedule 1, entry for Follitropin alfa with lutropin alfa
omit:
| Powder for injection 150 I.U.-75 I.U. with solvent | Injection | | Pergoveris | SG | MP | C5250 | | 14 | 0 | 1 | | D(100) |
[38] Schedule 1, entry for Griseofulvin in each of the forms: Tablet 125 mg; and Tablet 500 mg
omit from the column headed “Responsible Person”: QA substitute: AS
[39] Schedule 1, entry for Haloperidol in each of the forms: Injection 5 mg in 1 mL; Oral solution 2 mg per mL, 100 mL; Tablet 500 micrograms;
Tablet 1.5 mg; and Tablet 5 mg
omit from the column headed “Responsible Person”: QA substitute: AS
[40] Schedule 1, entry for Hydrocortisone in the form Cream containing hydrocortisone acetate 10 mg per g, 50 g
(a) omit from the column headed “Responsible Person” for the brand “Cortic-DS 1%” (all instances): FM substitute: LN
(b) omit from the column headed “Responsible Person” for the brand “Sigmacort” (all instances): QA substitute: AS
[41] Schedule 1, entry for Hydrocortisone in the form Eye ointment containing hydrocortisone acetate 10 mg per g, 5 g
omit from the column headed “Responsible Person”: QA substitute: AS
[42] Schedule 1, entry for Hydrocortisone in the form Ointment containing hydrocortisone acetate 10 mg per g, 50 g
(a) omit from the column headed “Responsible Person” for the brand “Cortic-DS 1%” (all instances): FM substitute: LN
(b) omit from the column headed “Responsible Person” for the brand “Sigmacort” (all instances): QA substitute: AS
[43] Schedule 1, entry for Hypromellose in the form Eye drops 5 mg per mL, 15 mL
omit from the column headed “Responsible Person”: QA substitute: AS
[44] Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]
(a) omit from the column headed “Circumstances” (all instances): C6510 C6526 C6538 C6557
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10010 C10026 C10035 C10048
(c) omit from the column headed “Purposes” (all instances): P6510 P6526 P6538 P6557
(d) insert in numerical order in the column headed “Purposes” (all instances): P10010 P10026 P10035 P10048
[45] Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 5]
(a) omit from the column headed “Circumstances” (all instances): C6510 C6526 C6538 C6557
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10010 C10026 C10035 C10048
[46] Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]
(a) omit from the column headed “Circumstances” (all instances): C6510 C6526 C6538 C6557
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10010 C10026 C10035 C10048
(c) omit from the column headed “Purposes” (all instances): P6510 P6526 P6538 P6557
(d) insert in numerical order in the column headed “Purposes” (all instances): P10010 P10026 P10035 P10048
[47] Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 5]
(a) omit from the column headed “Circumstances” (all instances): C6510 C6526 C6538 C6557
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10010 C10026 C10035 C10048
[48] Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]
(a) omit from the column headed “Circumstances” (all instances): C6510 C6526 C6538 C6557
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10010 C10026 C10035 C10048
(c) omit from the column headed “Purposes” (all instances): P6510 P6526 P6538 P6557
(d) insert in numerical order in the column headed “Purposes” (all instances): P10010 P10026 P10035 P10048
[49] Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 5]
(a) omit from the column headed “Circumstances” (all instances): C6510 C6526 C6538 C6557
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10010 C10026 C10035 C10048
[50] Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]
(a) omit from the column headed “Circumstances” (all instances): C6510 C6526 C6538 C6557
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10010 C10026 C10035 C10048
(c) omit from the column headed “Purposes” (all instances): P6510 P6526 P6538 P6557
(d) insert in numerical order in the column headed “Purposes” (all instances): P10010 P10026 P10035 P10048
[51] Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 5]
(a) omit from the column headed “Circumstances” (all instances): C6510 C6526 C6538 C6557
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10010 C10026 C10035 C10048
[52] Schedule 1, entry for Insulin glargine in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5
(a) insert in the column headed “Schedule Equivalent” for the brand “Lantus”: b
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Optisulin SoloStar | WA | MP NP | | | 5 | 1 | 1 | | |
[53] Schedule 1, entry for Ipratropium in each of the forms: Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30; and Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30
omit from the column headed “Responsible Person”: QA substitute: AS
[54] Schedule 1, entry for Labetalol in each of the forms: Tablet containing labetalol hydrochloride 100 mg; and Tablet containing labetalol hydrochloride 200 mg
omit from the column headed “Responsible Person”: QA substitute: AS
[55] Schedule 1, entry for Latanoprost
omit from the column headed “Responsible Person” for the brand “Xalaprost”: QA substitute: AS
[56] Schedule 1, entry for Latanoprost with timolol
omit from the column headed “Responsible Person” for the brand “Xalamol 50/5”: QA substitute: AS
[57] Schedule 1, entry for Letrozole
omit from the column headed “Responsible Person” for the brand “Fera”: QA substitute: AS
[58] Schedule 1, entry for Levothyroxine in each of the forms: Tablet containing 50 micrograms anhydrous levothyroxine sodium; Tablet containing 75 micrograms anhydrous levothyroxine sodium; Tablet containing 100 micrograms anhydrous levothyroxine sodium; and Tablet containing 200 micrograms anhydrous levothyroxine sodium
(a) omit from the column headed “Responsible Person” for the brand “Eutroxsig”: FM substitute: LN
(b) omit from the column headed “Responsible Person” for the brand “Oroxine”: QA substitute: AS
[59] Schedule 1, entry for Liothyronine
omit from the column headed “Responsible Person”: QA substitute: AS
[60] Schedule 1, entry for Mesalazine in each of the forms: Enemas 2 g in 60 mL, 7; Enemas 4 g in 60 mL, 7; Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g; Sachet containing granules, 500 mg per sachet; and Sachet containing granules, 1 g per sachet
omit from the column headed “Responsible Person”: OA substitute: FD
[61] Schedule 1, entry for Mesalazine in the form Sachet containing granules, 1.5 g per sachet
omit from the column headed “Responsible Person”: OA substitute: FD
[62] Schedule 1, entry for Mesalazine in the form Sachet containing granules, 3 g per sachet
omit from the column headed “Responsible Person”: OA substitute: FD
[63] Schedule 1, entry for Mesalazine in the form Suppository (moulded) 1 g
omit from the column headed “Responsible Person”: OA substitute: FD
[64] Schedule 1, entry for Mesalazine in the form Tablet 500 mg (enteric coated)
omit from the column headed “Responsible Person”: OA substitute: FD
[65] Schedule 1, entry for Mesalazine in the form Tablet 1 g (enteric coated)
omit from the column headed “Responsible Person”: OA substitute: FD
[66] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Metformin GH | HQ | MP NP | | | 100 | 5 | 100 | | |
[67] Schedule 1, entry for Methadone in the form Injection containing methadone hydrochloride 10 mg in 1 mL
omit from the column headed “Responsible Person”: QA substitute: AS
[68] Schedule 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L
omit from the column headed “Responsible Person”: QA substitute: AS
[69] Schedule 1, entry for Methadone in the form Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL
omit from the column headed “Responsible Person” for the brand “Aspen Methadone Syrup” (all instances): QA substitute: AS
[70] Schedule 1, entry for Methadone in the form Tablet containing methadone hydrochloride 10 mg
omit from the column headed “Responsible Person”: QA substitute: AS
[71] Schedule 1, entry for Methylprednisolone in the form Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g
omit from the column headed “Brand”: Advantan substitute: Advantan (Fatty)
[72] Schedule 1, entry for Minocycline
omit from the column headed “Responsible Person”: QA substitute: AS
[73] Schedule 1, entry for Mometasone in the form Cream containing mometasone furoate 1 mg per g, 15 g
omit from the column headed “Responsible Person” for the brand “Momasone” (all instances): QA substitute: AS
[74] Schedule 1, entry for Mometasone in the form Lotion containing mometasone furoate 1 mg per g, 30 mL
omit from the column headed “Responsible Person” for the brand “Momasone” (all instances): QA substitute: AS
[75] Schedule 1, entry for Mometasone in the form Ointment containing mometasone furoate 1 mg per g, 15 g
omit from the column headed “Responsible Person” for the brand “Momasone” (all instances): QA substitute: AS
[76] Schedule 1, entry for Morphine
omit:
| Injection containing morphine tartrate 120 mg in 1.5 mL | Injection | | Hospira Pty Limited | PF | MP NP | | | 5 | 0 | 5 | | |
[77] Schedule 1, entry for Nevirapine in the form Tablet 200 mg
(a) omit from the column headed “Schedule Equivalent” for the brand “Nevirapine Alphapharm”: a
(b) omit:
| | | a | Viramune | BY | MP | C4454 C4512 | | 120 | 5 | 60 | | D(100) |
[78] Schedule 1, entry for Nicorandil in each of the forms: Tablets 10 mg, 60; and Tablets 20 mg, 60
omit from the column headed “Responsible Person”: QA substitute: AS
[79] Schedule 1, entry for Nystatin in the form Capsule 500,000 units
omit from the column headed “Responsible Person”: QA substitute: AS
[80] Schedule 1, entry for Nystatin in the form Cream 100,000 units per g, 15 g
omit from the column headed “Responsible Person”: FM substitute: LN
[81] Schedule 1, entry for Nystatin in the form Tablet 500,000 units
omit from the column headed “Responsible Person”: QA substitute: AS
[82] Schedule 1, entry for Oxazepam in the form Tablet 15 mg
omit from the column headed “Responsible Person” for the brand “Serepax” (all instances): QA substitute: AS
[83] Schedule 1, entry for Oxazepam in the form Tablet 30 mg
omit from the column headed “Responsible Person” for the brand “Serepax” (all instances): QA substitute: AS
[84] Schedule 1, entry for Palbociclib in each of the forms: Capsule 75 mg; Capsule 100 mg; and Capsule 125 mg
omit from the column headed “Circumstances”: C9003 C9008 C9009 substitute: C10013 C10015 C10043
[85] Schedule 1, entry for Perhexiline
omit from the column headed “Responsible Person”: QA substitute: AS
[86] Schedule 1, entry for Phenobarbital in the form Injection 200 mg (as sodium) in 1 mL
omit from the column headed “Responsible Person”: FM substitute: AS
[87] Schedule 1, entry for Phenoxymethylpenicillin in the form Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL
omit from the column headed “Responsible Person”: FM substitute: AS
[88] Schedule 1, entry for Prednisolone in each of the forms: Suppositories 5 mg (as sodium phosphate), 10; and Enema, retention, 20 mg (as sodium phosphate) in 100 mL
omit from the column headed “Responsible Person”: QA substitute: AS
[89] Schedule 1, after entry for Primidone in the form Tablet 250 mg
insert:
| Tablet 250 mg (USP) | Oral | | APO-Primidone | LM | MP NP | | | 200 | 2 | 100 | | |
[90] Schedule 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 21; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C9005 C9006 C9014 C9017 C9021 C9024 C9025 C9026 C9029 substitute: C10018 C10037 C10038 C10044 C10054 C10057
(b) omit from the column headed “Purposes”: P9005 P9014 P9017 substitute: P10037 P10038
[91] Schedule 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 42; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C9005 C9006 C9014 C9017 C9021 C9024 C9025 C9026 C9029 substitute: C10018 C10037 C10038 C10044 C10054 C10057
(b) omit from the column headed “Purposes”: P9006 P9024 P9026 substitute: P10044 P10054
[92] Schedule 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 63; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C9005 C9006 C9014 C9017 C9021 C9024 C9025 C9026 C9029 substitute: C10018 C10037 C10038 C10044 C10054 C10057
(b) omit from the column headed “Purposes”: P9021 P9025 P9029 substitute: P10018 P10057
[93] Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 2]
(a) omit from the column headed “Circumstances”: C5993 C6897 C6938
(b) insert in numerical order in the column headed “Circumstances”: C6898 C6899 C10020 C10021 C10052
(c) omit from the column headed “Purposes”: P5993 P6897 P6938 substitute: P6898 P6899 P10020 P10021 P10052
[94] Schedule 1, entry for Risperidone in the form Oral solution 1 mg per mL, 100 mL [Maximum Quantity: 1; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C5993 C6897 C6938
(b) insert in numerical order in the column headed “Circumstances”: C6898 C6899 C10020 C10021 C10052
[95] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a) omit from the column headed “Circumstances” (all instances): C6010
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10020 C10021 C10052
(c) omit from the column headed “Purposes” (all instances): P6010
(d) insert in numerical order in the column headed “Purposes” (all instances): P10020 P10021 P10052
[96] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a) omit from the column headed “Circumstances” (all instances): C6010
(b) insert in numerical order in the column headed “Circumstances” (all instances): C10020 C10021 C10052
[97] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]
(a) omit from the column headed “Circumstances” (all instances): C5993 C6897 C6938
(b) insert in numerical order in the column headed “Circumstances” (all instances): C6898 C6899 C10020 C10021 C10052
(c) omit from the column headed “Purposes” (all instances): P5993 P6897 P6938 substitute: P6898 P6899 P10020 P10021 P10052
[98] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]
(a) omit from the column headed “Circumstances” (all instances): C5993 C6897 C6938
(b) insert in numerical order in the column headed “Circumstances” (all instances): C6898 C6899 C10020 C10021 C10052
[99] Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Truxima | EW | MP | C7399 C7400 C9451 C9542 | | See Note 3 | See Note 3 | 2 | | PB(100) |
[100] Schedule 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Truxima | EW | MP | C7399 C7400 C9451 C9542 | | See Note 3 | See Note 3 | 1 | | PB(100) |
[101] Schedule 1, entry for Somatropin in the form Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)
(a) omit from the column headed “Circumstances”: C9300 C9301
(b) insert in numerical order in the column headed “Circumstances”: C10011 C10012 C10027 C10042
[102] Schedule 1, entry for Somatropin in the form Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)
(a) omit from the column headed “Circumstances”: C9300 C9301
(b) insert in numerical order in the column headed “Circumstances”: C10011 C10012 C10027 C10042
[103] Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)
(a) omit from the column headed “Circumstances”: C9300 C9301
(b) insert in numerical order in the column headed “Circumstances”: C10011 C10012 C10027 C10042
[104] Schedule 1, entry for Tamoxifen in the form Tablet 20 mg (as citrate)
omit from the column headed “Responsible Person”: QA substitute: AS
[105] Schedule 1, entry for Temazepam
(a) omit from the column headed “Responsible Person” for the brand “Normison” (all instances): QA substitute: AS
(b) omit from the column headed “Responsible Person” for the brand “Temtabs” (all instances): FM substitute: LN
[106] Schedule 1, entry for Temozolomide in the form Capsule 5 mg
omit from the column headed “Responsible Person” for the brand “Temizole 5” (all instances): QA substitute: AS
[107] Schedule 1, entry for Temozolomide in the form Capsule 20 mg
omit from the column headed “Responsible Person” for the brand “Temizole 20” (all instances): QA substitute: AS
[108] Schedule 1, entry for Temozolomide in the form Capsule 100 mg
omit from the column headed “Responsible Person” for the brand “Temizole 100” (all instances): QA substitute: AS
[109] Schedule 1, entry for Temozolomide in the form Capsule 140 mg
omit from the column headed “Responsible Person” for the brand “Temizole 140” (all instances): QA substitute: AS
[110] Schedule 1, entry for Temozolomide in the form Capsule 250 mg
omit from the column headed “Responsible Person” for the brand “Temizole 250”: QA substitute: AS
[111] Schedule 1, entry for Teriflunomide
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Pharmacor Teriflunomide | CR | MP | C6854 C7741 | | 28 | 5 | 28 | | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Teriflunomide GH | GQ | MP | C6854 C7741 | | 28 | 5 | 28 | | |
[112] Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C6778
(b) insert in numerical order in the column headed “Circumstances”: C10051
(c) omit from the column headed “Purposes”: P6778
(d) insert in numerical order in the column headed “Purposes”: P10051
[113] Schedule 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C6778
(b) insert in numerical order in the column headed “Circumstances”: C10051
[114] Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C6778
(b) insert in numerical order in the column headed “Circumstances”: C10051
(c) omit from the column headed “Purposes”: P6778
(d) insert in numerical order in the column headed “Purposes”: P10051
[115] Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C6778
(b) insert in numerical order in the column headed “Circumstances”: C10051
[116] Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Ontruzant | MK | MP | C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628 | | See Note 3 | See Note 3 | 1 | | PB(100) |
[117] Schedule 1, entry for Triamcinolone in the form Cream containing triamcinolone acetonide 200 micrograms per g, 100 g
(a) omit from the column headed “Responsible Person”: QA substitute: AS
(b) omit from the column headed “Responsible Person”: FM substitute: LN
[118] Schedule 1, entry for Triamcinolone in the form Injection containing triamcinolone acetonide 10 mg in 1 mL
omit from the column headed “Responsible Person”: QA substitute: AS
[119] Schedule 1, entry for Triamcinolone in the form Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g
(a) omit from the column headed “Responsible Person”: QA substitute: AS
(b) omit from the column headed “Responsible Person”: FM substitute: LN
[120] Schedule 1, entry for Triamcinolone with neomycin, gramicidin and nystatin in the form Ear drops containing triamcinolone acetonide 0.9 mg with neomycin 2.25 mg (as sulfate), gramicidin 225 micrograms and nystatin 90,000 units per mL, 7.5 mL
(a) omit from the column headed “Responsible Person”: QA substitute: AS
(b) omit from the column headed “Responsible Person”: FM substitute: LN
[121] Schedule 1, entry for Triamcinolone with neomycin, gramicidin and nystatin in the form Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g
(a) omit from the column headed “Responsible Person”: QA substitute: AS
(b) omit from the column headed “Responsible Person”: FM substitute: LN
[122] Schedule 1, entry for Ursodeoxycholic acid in each of the forms: Capsule 250 mg; and Tablet 500 mg
omit from the column headed “Responsible Person”: OA substitute: FD
[123] Schedule 1, omit entry for Verteporfin
[124] Schedule 3, after details relevant to Responsible Person code FB
insert:
FD | Dr Falk Pharma Australia Pty Ltd | 40 631 091 131 |
[125] Schedule 3
omit:
FM | Fawns and McAllan Proprietary Limited | 16 004 296 066 |
[126] Schedule 3
omit:
OA | Orphan Australia Pty Ltd | 11 067 189 342 |
[127] Schedule 4, Part 1, after entry for Abatacept
insert:
Abemaciclib | C10019 | | | Locally advanced or metastatic breast cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with palbociclib or ribociclib.
Patient must not be premenopausal.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. | Compliance with Authority Required procedures |
| C10032 | | | Locally advanced or metastatic breast cancer
Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
Patient must not have previously been treated with palbociclib or ribociclib; OR
Patient must have developed an intolerance to palbociclib or ribociclib of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with palbociclib or ribociclib.
Patient must not be premenopausal. | Compliance with Authority Required procedures |
[128] Schedule 4, Part 1, entry for Avelumab
(a) omit:
| C8856 | | | Stage IV (metastatic) Merkel Cell Carcinoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 12 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 8856 |
(b) insert in numerical order after existing text:
| C10023 | | | Stage IV (metastatic) Merkel Cell Carcinoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10023 |
[129] Schedule 4, Part 1, entry for Cobimetinib
(a) omit:
| C6839 | P6839 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition; AND
Patient must not have progressive disease when treated with a BRAF inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 6839 |
(b) insert in numerical order after existing text:
| C10033 | P10033 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10033 |
[130] Schedule 4, Part 1, entry for Imatinib
(a) omit:
| C6510 | P6510 | | Chronic Myeloid Leukaemia (CML)
Initial treatment
Patient must have a primary diagnosis of chronic myeloid leukaemia; AND
The condition must be in the accelerated phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase.
Accelerated phase is defined by the presence of 1 or more of the following:
1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
3. Peripheral basophils greater than or equal to 20%; or
4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Imatinib Mesilate PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and
(c) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly | Compliance with Written Authority Required procedures |
| C6526 | P6526 | | Chronic Myeloid Leukaemia (CML)
Initial treatment
Patient must a primary diagnosis of chronic myeloid leukaemia; AND
The condition must be in the blast phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase.
Blast crisis is defined as either:
1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
2. Extramedullary involvement other than spleen and liver.
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Imatinib Mesilate PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and
(c) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement | Compliance with Written Authority Required procedures |
| C6538 | P6538 | | Chronic Myeloid Leukaemia (CML)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be in the accelerated phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase. | Compliance with Authority Required procedures |
| C6557 | P6557 | | Chronic Myeloid Leukaemia (CML)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be in the blast phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase. | Compliance with Authority Required procedures |
(b) insert in numerical order after existing text:
| C10010 | P10010 | | Chronic Myeloid Leukaemia (CML)
Initial treatment
Patient must have a primary diagnosis of chronic myeloid leukaemia; AND
The condition must be in the accelerated phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase.
Accelerated phase is defined by the presence of 1 or more of the following:
1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or
2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or
3. Peripheral basophils greater than or equal to 20%; or
4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or
5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). | Compliance with Authority Required procedures |
| C10026 | P10026 | | Chronic Myeloid Leukaemia (CML)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be in the accelerated phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase. | Compliance with Authority Required procedures - Streamlined Authority Code 10026 |
| C10035 | P10035 | | Chronic Myeloid Leukaemia (CML)
Initial treatment
Patient must a primary diagnosis of chronic myeloid leukaemia; AND
The condition must be in the blast phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase.
Blast crisis is defined as either:
1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or
2. Extramedullary involvement other than spleen and liver. | Compliance with Authority Required procedures |
| C10048 | P10048 | | Chronic Myeloid Leukaemia (CML)
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be in the blast phase; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase. | Compliance with Authority Required procedures - Streamlined Authority Code 10048 |
[131] Schedule 4, Part 1, entry for Palbociclib
substitute:
Palbociclib | C10013 | | | Locally advanced or metastatic breast cancer
Initial treatment - Grandfather patients
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 May 2019; AND
Patient must not have previously been treated with an aromatase inhibitor prior to initiating treatment with this drug for this condition; AND
Patient must not have previously been treated with abemaciclib or ribociclib; OR
Patient must have developed an intolerance to abemaciclib or ribociclib of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less prior to initiating treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or ribociclib.
Patient must not be premenopausal.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures |
| C10015 | | | Locally advanced or metastatic breast cancer
Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
Patient must not have previously been treated with abemaciclib or ribociclib; OR
Patient must have developed an intolerance to abemaciclib or ribociclib of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or ribociclib.
Patient must not be premenopausal. | Compliance with Authority Required procedures |
| C10043 | | | Locally advanced or metastatic breast cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or ribociclib.
Patient must not be premenopausal.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. | Compliance with Authority Required procedures |
[132] Schedule 4, Part 1, entry for Ribociclib
substitute:
Ribociclib | C10018 | P10018 | | Locally advanced or metastatic breast cancer
Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
Patient must not have previously been treated with abemaciclib or palbociclib; OR
Patient must have developed an intolerance to abemaciclib or palbociclib of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or palbociclib.
Patient must not be premenopausal. | Compliance with Authority Required procedures |
| C10037 | P10037 | | Locally advanced or metastatic breast cancer
Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
Patient must not have previously been treated with abemaciclib or palbociclib; OR
Patient must have developed an intolerance to abemaciclib or palbociclib of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or palbociclib; AND
Patient must require dosage reduction requiring a pack of 21 tablets.
Patient must not be premenopausal. | Compliance with Authority Required procedures |
| C10038 | P10038 | | Locally advanced or metastatic breast cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or palbociclib; AND
Patient must require dosage reduction requiring a pack of 21 tablets.
Patient must not be premenopausal.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. | Compliance with Authority Required procedures |
| C10044 | P10044 | | Locally advanced or metastatic breast cancer
Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
Patient must not have previously been treated with abemaciclib or palbociclib; OR
Patient must have developed an intolerance to abemaciclib or palbociclib of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or palbociclib; AND
Patient must require dosage reduction requiring a pack of 42 tablets.
Patient must not be premenopausal. | Compliance with Authority Required procedures |
| C10054 | P10054 | | Locally advanced or metastatic breast cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or palbociclib; AND
Patient must require dosage reduction requiring a pack of 42 tablets.
Patient must not be premenopausal.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. | Compliance with Authority Required procedures |
| C10057 | P10057 | | Locally advanced or metastatic breast cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with abemaciclib or palbociclib.
Patient must not be premenopausal.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. | Compliance with Authority Required procedures |
[133] Schedule 4, Part 1, entry for Risperidone
(a) omit:
| C5993 | P5993 | | Behavioural disturbances
The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia of the Alzheimer type; AND
Patient must have failed to respond to non-pharmacological methods of treatment; AND
The treatment must be limited to a maximum duration of 12 weeks. | Compliance with Authority Required procedures - Streamlined Authority Code 5993 |
| C6010 | P6010 | | Behavioural disturbances
The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia of the Alzheimer type; AND
Patient must have failed to respond to non-pharmacological methods of treatment; AND
The treatment must be limited to a maximum duration of 12 weeks. | Compliance with Authority Required procedures - Streamlined Authority Code 6010 |
(b) insert in numerical order after existing text:
| C10020 | P10020 | | Behavioural disturbances
Initial treatment
The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia of the Alzheimer type; AND
Patient must have failed to respond to non-pharmacological methods of treatment; AND
Patient must not receive more than 12 weeks of treatment under this restriction.
A patient may only qualify for 12 weeks of PBS-subsidised treatment under this restriction once in a 12 month period. | Compliance with Authority Required procedures - Streamlined Authority Code 10020 |
| C10021 | P10021 | | Behavioural disturbances
Continuing treatment, trial of dose reduction or cessation of treatment
The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia of the Alzheimer type; AND
Patient must have responded to an initial course of treatment with this drug for this condition; AND
Patient must have failed to respond to non-pharmacological methods of treatment; AND
The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; OR
Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND
Patient must be optimised on non-pharmacological methods of treatment.
The patient's response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.
Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.
Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.
Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.
Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy.
Evidence of patient benefit from therapy, failure of non-pharmacological approaches to manage symptoms in the absence of therapy, and recurrence of symptoms following reduction or cessation of therapy, trialled on at least 1 occasion, must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C10052 | P10052 | | Behavioural disturbances
Grandfather treatment for the trial of dose reduction or cessation of treatment in a patient prescribed risperidone prior to 1 January 2020
The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia of the Alzheimer type; AND
Patient must have received PBS-subsidised treatment with this drug for this condition prior to 1 January 2020; AND
Patient must have responded to PBS-subsidised treatment with this drug for this condition; AND
Patient must have failed to respond to non-pharmacological methods of treatment; AND
Patient must be optimised on non-pharmacological methods of treatment; AND
The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; OR
Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND
Patient must not receive more than 12 weeks of treatment under this restriction.
A patient may only qualify for PBS-subsidised treatment under this restriction once in a lifetime.
The patient's response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.
Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.
Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.
Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.
Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 10052 |
[134] Schedule 4, Part 1, entry for Somatropin
(a) omit:
| C9300 | | | Severe growth hormone deficiency
Initial treatment
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND
Patient must have an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must be aged 18 years or older.
Grandfathered patient who has previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2018 must have met all the initial restriction criteria prior to initiating non-PBS subsidised treatment. Additional information of a baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks prior to initiating non-PBS subsidised treatment with this drug for this condition must be provided at the time of application. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Confirmation of childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Confirmation of adult onset growth hormone deficiency due to organic hypothalamic or pituitary disease; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender; AND
A baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
| C9301 | | | Severe growth hormone deficiency
Continuing treatment
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition at the age of 18 years or older; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
Patient must be aged 18 years or older.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
(b) insert in numerical order after existing text:
| C10011 | | | Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND
Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must have a mature skeleton.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
| C10012 | | | Severe growth hormone deficiency
Continuing treatment in adults
Must be treated by an endocrinologist or in consultation with an endocrinologist.
Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR
Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND
Patient must maintain IGF-1 levels within the normal range for age and sex.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
| C10027 | | | Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child.
Patient must have a mature skeleton.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application. | Compliance with Written Authority Required procedures |
| C10042 | | | Severe growth hormone deficiency
Initial treatment of adult onset growth hormone deficiency
Must be treated by an endocrinologist.
Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND
Patient must have an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must be aged 18 years or older.
Grandfathered patient who has previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2018 must have met all the initial restriction criteria prior to initiating non-PBS subsidised treatment. Additional information of a baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks prior to initiating non-PBS subsidised treatment with this drug for this condition must be provided at the time of application. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender; AND
A baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old prior to initiating treatment. | Compliance with Written Authority Required procedures |
[135] Schedule 4, Part 1, entry for Trametinib
(a) omit:
| C6778 | P6778 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition; AND
Patient must not have had progressive disease when treated with a BRAF inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 6778 |
(b) insert in numerical order after existing text:
| C10051 | P10051 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 10051 |
[136] Schedule 4, Part 1, omit entry for Verteporfin
[137] Schedule 5, entry for Abacavir with lamivudine in the form Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg [GRP-21981]
omit from the column headed “Brand”: Abacavir/Lamivudine 600/300 APOTEX
1 Name of Instrument