National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 13) (No. PB 74 of 2013) (Cth)
PB 74 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 13)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 26 NOVEMBER 2013
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 13).
(2) This Instrument may also be cited as PB 74 of 2013.
2 Commencement
This Instrument commences on 1 December 2013.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
Schedule 1, after entry for Allopurinol in the form Tablet 300 mg [Zyloprim]
insert:
| Alogliptin | Tablet 6.25 mg (as benzoate) | Oral | Nesina | TK | MP NP | C4349 | 28 | 5 | 28 |
| Tablet 12.5 mg (as benzoate) | Oral | Nesina | TK | MP NP | C4349 | 28 | 5 | 28 | |
| Tablet 25 mg (as benzoate) | Oral | Nesina | TK | MP NP | C4349 | 28 | 5 | 28 |
Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
insert as first item in the columns in the order indicated:
| Oral powder 400 g (Alfamino) | Oral | Alfamino | NT | MP NP | C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 | 8 | 5 | 1 |
Schedule 1, entry for Anastrozole
omit:
| STADA Anastrozole | TD | MP NP | C2213 | 30 | 5 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium)
(a)omit:
| STADA Atorvastatin | TD | MP | C1540 C3047 | P1540 | 30 | 5 | 30 |
| NP | C1540 | 30 | 5 | 30 |
(b)omit:
| STADA Atorvastatin | TD | MP | C1540 C3047 | P3047 | 30 | 11 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium)
(a)omit:
| STADA Atorvastatin | TD | MP | C1540 C3047 | P1540 | 30 | 5 | 30 |
| NP | C1540 | 30 | 5 | 30 |
(b)omit:
| STADA Atorvastatin | TD | MP | C1540 C3047 | P3047 | 30 | 11 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium)
(a)omit:
| STADA Atorvastatin | TD | MP | C1540 C3047 | P1540 | 30 | 5 | 30 |
| NP | C1540 | 30 | 5 | 30 |
(b)omit:
| STADA Atorvastatin | TD | MP | C1540 C3047 | P3047 | 30 | 11 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium)
(a)omit:
| STADA Atorvastatin | TD | MP | C1540 C3047 | P1540 | 30 | 5 | 30 |
| NP | C1540 | 30 | 5 | 30 |
(b)omit:
| STADA Atorvastatin | TD | MP | C1540 C3047 | P3047 | 30 | 11 | 30 |
Schedule 1, after entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Brand: Trovas; Maximum Quantity: 30;
Number of Repeats: 11]
insert:
| Atorvastatin and ezetimibe | Pack containing 30 tablets atorvastatin 10 mg (as calcium) and 30 tablets ezetemibe 10 mg | Oral | Atozet Composite Pack 10mg + 10mg | MK | MP NP | C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 C4353 | 1 | 5 | 1 |
| Pack containing 30 tablets atorvastatin 20 mg (as calcium) and 30 tablets ezetemibe 10 mg | Oral | Atozet Composite Pack 10mg + 20mg | MK | MP NP | C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 | 1 | 5 | 1 | |
| Pack containing 30 tablets atorvastatin 40 mg (as calcium) and 30 tablets ezetemibe 10 mg | Oral | Atozet Composite Pack 10mg + 40mg | MK | MP NP | C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 | 1 | 5 | 1 | |
| Pack containing 30 tablets atorvastatin 80 mg (as calcium) and 30 tablets ezetemibe 10 mg | Oral | Atozet Composite Pack 10mg + 80mg | MK | MP NP | C4068 C4069 C4085 C4086 C4096 C4097 C4120 C4121 | 1 | 5 | 1 |
Schedule 1, entry for Bimatoprost with timolol
substitute:
| Bimatoprost with timolol | Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL | Application to the eye | Ganfort 0.3/5 | AG | MP | C4343 | 1 | 5 | 1 |
| AO | C4326 | 1 | 5 | 1 |
Schedule 1, entry for Brimonidine with Timolol
substitute:
| Brimonidine with timolol | Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL | Application to the eye | Combigan | AG | MP | C4343 | 1 | 5 | 1 |
| AO | C4326 | 1 | 5 | 1 |
Schedule 1, entry for Brinzolamide with timolol
substitute:
| Brinzolamide with timolol | Eye drops 10 mg brinzolamide with timolol 5 mg (as maleate) per mL, 5 mL | Application to the eye | Azarga | AQ | MP | C4343 | 1 | 5 | 1 |
| AO | C4326 | 1 | 5 | 1 |
Schedule 1, after entry for Budesonide with Eformoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2
insert in the columns in the order indicated:
| Pressurised inhalation containing budesonide 50 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2 | Inhalation by mouth | Symbicort Rapihaler 50/3 | AP | MP NP | C4318 | 1 | 5 | 1 |
| Pressurised inhalation containing budesonide 100 micrograms with eformoterol fumarate dihydrate 3 micrograms per dose, 120 doses, 2 | Inhalation by mouth | Symbicort Rapihaler 100/3 | AP | MP NP | C4318 | 1 | 5 | 1 |
| Pressurised inhalation containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses, 2 | Inhalation by mouth | Symbicort Rapihaler 200/6 | AP | MP NP | C4327 C4333 | 1 | 5 | 1 |
Schedule 1, after entry for Calcium in the form Tablet 600 mg (as carbonate)
insert:
| Canagliflozin | Tablet 100 mg (as hemihydrate) | Oral | Invokana | JC | MP NP | C4321 | 30 | 5 | 30 |
| Tablet 300 mg (as hemihydrate) | Oral | Invokana | JC | MP NP | C4321 | 30 | 5 | 30 |
Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Candesartan 4 | DO | MP NP | 30 | 5 | 30 |
(b)omit:
| STADA Candesartan | TD | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Candesartan 8 | DO | MP NP | 30 | 5 | 30 |
(b)omit:
| STADA Candesartan | TD | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Candesartan 16 | DO | MP NP | 30 | 5 | 30 |
(b)omit:
| STADA Candesartan | TD | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Auro-Candesartan 32 | DO | MP NP | 30 | 5 | 30 |
(b)omit:
| STADA Candesartan | TD | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
omit:
| STADA Candesartan HCT 16/12.5 | TD | MP NP | C3307 | 30 | 5 | 30 |
Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
omit:
| STADA Candesartan HCT 32/12.5 | TD | MP NP | C3307 | 30 | 5 | 30 |
Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
omit:
| STADA Candesartan HCT 32/25 | TD | MP NP | C3307 | 30 | 5 | 30 |
Schedule 1, entry for Carbamazepine in the form Tablet 200 mg [Maximum Quantity 200; Number of Repeats 0]
omit:
| Carbamazepine Sandoz | SZ | PDP | 200 | 0 | 200 |
substitute:
| Carbamazepine Sandoz | SZ | PDP | 200 | 0 | 100 |
| PDP | 200 | 0 | 200 |
Schedule 1, entry for Carbamazepine in the form Tablet 200 mg [Maximum Quantity 200; Number of Repeats 2]
omit:
| Carbamazepine Sandoz | SZ | MP NP | 200 | 2 | 200 |
substitute:
| Carbamazepine Sandoz | SZ | MP NP | 200 | 2 | 100 |
| MP NP | 200 | 2 | 200 |
Schedule 1, entry for Carbimazole in the form Tablet 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Carbimazol ARISTO | PQ | MP NP | 200 | 2 | 100 |
Schedule 1, entry for Ceftriaxone in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)
omit from the column headed “Brand”: DBL Ceftriaxone substitute: Hospira Ceftriaxone
Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit from the column headed “Brand”: Clarihexal substitute: Clarithromycin Sandoz
Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
omit:
| STADA Clopidogrel | TD | MP NP | C1719 C1720 C1721 C1722 C1723 C1724 | 28 | 5 | 28 |
Schedule 1, after entry for Dabigatran etexilate in the form Capsule 150 mg (as mesilate)
insert:
| Dabrafenib | Capsule 50 mg (as mesilate) | Oral | Tafinlar | GK | MP | C4317 C4340 | P4317 | 120 | 3 | 120 |
| MP | C4317 C4340 | P4340 | 120 | 5 | 120 | |||||
| Capsule 75 mg (as mesilate) | Oral | Tafinlar | GK | MP | C4317 C4340 | P4317 | 120 | 3 | 120 | |
| MP | C4317 C4340 | P4340 | 120 | 5 | 120 |
Schedule 1, after entry for Dantrolene in the form Capsule containing dantrolene sodium 50 mg
insert:
| Dapagliflozin | Tablet 10 mg (as propanediol monohydrate) | Oral | Forxiga | BQ | MP NP | C4331 | 28 | 5 | 28 |
Schedule 1, entry for Darunavir in the form Tablet 400 mg (as ethanolate)
omit from the column headed “Circumstances”: C3940 C3941 substitute: C4313 C4346
Schedule 1, after entry for Darunavir in the form Tablet 600 mg (as ethanolate)
insert in the columns in the order indicated:
| Tablet 800 mg (as ethanolate) | Oral | Prezista | JC | MP See Note 1 | C4313 C4346 | 60 | 5 | 30 | D(100) |
Schedule 1, entry for Denosumab in the form Injection 60 mg in 1 mL pre-filled syringe
omit from the column headed “Circumstances”: C4094 C4145 substitute: C4314 C4347
Schedule 1, after entry for Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg [Vasocardol CD]
insert in the columns in the order indicated:
| Dimethyl fumarate | Capsule (modified release) 120 mg | Oral | Tecfidera | BD | MP | C4320 C4335 | 14 | 0 | 14 |
| Capsule (modified release) 240 mg | Oral | Tecfidera | BD | MP | C4356 | 56 | 5 | 56 |
Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing
donepezil hydrochloride 10 mg
omit:
| STADA Donepezil | TD | MP NP | C4219 C4220 C4224 | 28 | 5 | 28 |
Schedule 1, entry for Dorzolamide with Timolol
substitute:
| Dorzolamide with timolol | Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL | Application to the eye | Cosopt | MK | MP | C4343 | 1 | 5 | 1 | 1 |
| AO | C4326 | 1 | 5 | 1 | 1 |
Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Deotine 30 | SZ | MP NP | C1211 | 28 | 0 | 28 |
Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Deotine 60 | SZ | MP NP | C1211 | 28 | 5 | 28 |
Schedule 1, after entry for Everolimus in the form Tablet 1 mg
insert in the columns in the order indicated:
| Tablet 2.5 mg | Oral | Afinitor | NV | MP | C4334 C4351 | 30 | 5 | 30 |
| Tablet 5 mg | Oral | Afinitor | NV | MP | C4334 C4351 | 30 | 5 | 30 |
| Tablet 10 mg | Oral | Afinitor | NV | MP | C4334 C4351 | 30 | 5 | 30 |
Schedule 1, after entry for Fluticasone in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses
insert:
| Fluticasone with eformoterol | Pressurised inhalation containing fluticasone propionate 50 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses | Inhalation by mouth | flutiform 50/5 | MF | MP NP | C4315 | 1 | 5 | 1 |
| Pressurised inhalation containing fluticasone propionate 125 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses | Inhalation by mouth | flutiform 125/5 | MF | MP NP | C4315 | 1 | 5 | 1 | |
| Pressurised inhalation containing fluticasone propionate 250 micrograms with eformoterol fumarate dihydrate 10 micrograms per dose, 120 doses | Inhalation by mouth | flutiform 250/10 | MF | MP NP | C4315 | 1 | 5 | 1 |
Schedule 1, entry for Ifosfamide in each of the forms: Powder for I.V. injection 1 g in single dose vial; and Powder for I.V. injection 2 g in single dose vial
(a)omit from the column headed “Form”: in single dose vial
(b)omit from the column headed “Circumstances”: C1325 C1327
Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Maximum Quantity 60; Number of Repeats 2]
(a)omit from the column headed “Circumstances”: C3847 C3848
(b)insert in numerical order”: C4342 C4355
Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Maximum Quantity 60; Number of Repeats 5]
(a)omit from the column headed “Circumstances”: C3847 C3848
(b)insert in numerical order”: C4342 C4355
(c)omit from the column headed “Purposes”: P3847 P3848
(d)insert in numerical order”: P4342 P4355
Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Maximum Quantity 30; Number of Repeats 2]
(a)omit from the column headed “Circumstances”: C3847 C3848
(b)insert in numerical order”: C4342 C4355
Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Maximum Quantity 30; Number of Repeats 5]
(a)omit from the column headed “Circumstances”: C3847 C3848
(b)insert in numerical order”: C4342 C4355
(c)omit from the column headed “Purposes”: P3847 P3848
(d)insert in numerical order”: P4342 P4355
Schedule 1, entry for Insulin Isophane in the form Injection (bovine) 100 units per mL, 10 mL
insert in the column headed “Circumstances”: C4332
Schedule 1, entry for Insulin Neutral in the form Injection (bovine) 100 units per mL, 10 mL
insert in the column headed “Circumstances”: C4332
Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg
omit:
| STADA Irbesartan | TD | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg
omit:
| STADA Irbesartan HCT 150/12.5 | TD | MP NP | C3307 | 30 | 5 | 30 |
Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
omit:
| STADA Irbesartan HCT 300/12.5 | TD | MP NP | C3307 | 30 | 5 | 30 |
Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg
omit:
| STADA Irbesartan HCT 300/25 | TD | MP NP | C3307 | 30 | 5 | 30 |
Schedule 1, after entry for Itraconazole
insert:
| Ivabradine | Tablet 5 mg (as hydrochloride) | Oral | Coralan | SE | MP NP | C4310 | 56 | 5 | 56 |
| Tablet 7.5 mg (as hydrochloride) | Oral | Coralan | SE | MP NP | C4310 | 56 | 5 | 56 |
Schedule 1, entry for Ivermectin
substitute:
| Ivermectin | Tablet 3 mg | Oral | Stromectol | MK | MP NP | C4319 C4328 | P4319 | 4 | 0 | 4 |
| MP NP | C4319 C4328 | P4328 | 8 | 2 | 4 |
Schedule 1, entry for Ketoconazole
omit:
| Tablet 200 mg | Oral | Nizoral | JC | MP NP | C3604 C3605 C3606 | P3606 | 10 | 0 | 10 |
| MP NP | C3604 C3605 C3606 | P3604 P3605 | 30 | 5 | 10 |
Schedule 1, entry for Latanoprost
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Latanoprost Actavis | GN | MP AO | 1 | 5 | 1 |
Schedule 1, entry for Latanoprost with Timolol
substitute:
| Latanoprost with timolol | Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Application to the eye | Latanocom | FZ | MP | C4343 | 1 | 5 | 1 |
| AO | C4326 | 1 | 5 | 1 | |||||
| Xalacom | PF | MP | C4343 | 1 | 5 | 1 | |||
| AO | C4326 | 1 | 5 | 1 |
Schedule 1, entry for Letrozole
omit:
| STADA Letrozole | TD | MP NP | C1608 C2691 C2692 | 30 | 5 | 30 |
Schedule 1, entry for Linagliptin
omit from the column headed “Circumstances”: C3540 substitute: C4350
Schedule 1, entry for Macrogol 3350
omit:
| Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Oral | LaxaCon | GN | MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3643 See Note 2 | 2 See Note 2 | 0 See Note 2 | 1 |
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3642 See Note 2 | 2 See Note 2 | 3 See Note 2 | 1 | |||||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P1263 P1613 P2693 P2823 See Note 2 | 1 See Note 2 | 5 See Note 2 | 1 | |||||
| Movicol | NE | MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3643 See Note 2 | 2 See Note 2 | 0 See Note 2 | 1 | |||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3642 See Note 2 | 2 See Note 2 | 3 See Note 2 | 1 | |||||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P1263 P1613 P2693 P2823 See Note 2 | 1 See Note 2 | 5 See Note 2 | 1 |
substitute:
| Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Oral | LaxaCon | GN | MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3643 See Note 2 | 2 See Note 2 | 0 See Note 2 | 1 |
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3642 See Note 2 | 2 See Note 2 | 3 See Note 2 | 1 | |||||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P1263 P1613 P2693 P2823 See Note 2 | 1 See Note 2 | 5 See Note 2 | 1 | |||||
| lax-sachets | AE | MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3643 See Note 2 | 2 See Note 2 | 0 See Note 2 | 1 | |||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3642 See Note 2 | 2 See Note 2 | 3 See Note 2 | 1 | |||||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P1263 P1613 P2693 P2823 See Note 2 | 1 See Note 2 | 5 See Note 2 | 1 | |||||
| Movicol | NE | MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3643 See Note 2 | 2 See Note 2 | 0 See Note 2 | 1 | |||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P3642 See Note 2 | 2 See Note 2 | 3 See Note 2 | 1 | |||||
| MP NP See Note 1 | C1263 C1613 C2693 C2823 C3642 C3643 See Note 2 | P1263 P1613 P2693 P2823 See Note 2 | 1 See Note 2 | 5 See Note 2 | 1 |
Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
(a)omit:
| APO-Metoprolol | TX | MP NP | 100 | 5 | 100 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Metatar | FM | MP NP | 100 | 5 | 100 |
Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
(a)omit:
| APO-Metoprolol | TX | MP NP | 60 | 5 | 60 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Metatar | FM | MP NP | 60 | 5 | 60 |
Schedule 1, entry for Miconazole in the form Tincture 20 mg per mL, 30 mL
omit from the column headed “Brand”: Daktarin substitute: Daktarin Tincture
Schedule 1, after entry for Milk powder—lactose free formula in the form Oral powder 900 g (Karicare Aptamil De‑Lact)
insert in the columns in the order indicated:
| Oral powder 900 g (Karicare Aptamil Gold De‑Lact) | Oral | Karicare Aptamil Gold De‑Lact | NU | MP NP | C4324 C4336 | P4324 | 5 | 0 | 1 |
| MP NP | C4324 C4336 | P4336 | 5 | 5 | 1 |
Schedule 1, entry for Nicotine in the form Transdermal patch 17.5 mg
(a)omit from the column headed “Circumstances”: C3447 C3448 substitute: C4307 C4348
(b)omit from the column headed “Number of Repeats”: 0 substitute: 2
Schedule 1, entry for Nicotine in the form Transdermal patch 24.9 mg
omit from the column headed “Circumstances”: C4231 C4232 C4233 substitute: C4307 C4344 C4348
Schedule 1, entry for Nicotine in the form Transdermal patch 35 mg
(a)omit from the column headed “Circumstances”: C3447 C3448 substitute: C4307 C4348
(b)omit from the column headed “Number of Repeats”: 0 substitute: 2
Schedule 1, entry for Nicotine
omit:
| Transdermal patch 52.5 mg | Transdermal | Nicotinell Step 1 | NC | MP NP | C3042 C3447 C3448 | P3447 P3448 | 28 | 0 | 28 |
| MP NP | C3042 C3447 C3448 | P3042 | 28 | 2 | 28 |
substitute:
| Transdermal patch 52.5 mg | Transdermal | Nicotinell Step 1 | NC | MP NP | C4307 C4344 C4348 | 28 | 2 | 28 |
Schedule 1, entry for Nicotine in the form Transdermal patch 114 mg
omit from the column headed “Circumstances”: C4231 C4232 C4233 substitute: C4307 C4344 C4348
Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg
(as benzoate); and Tablet 10 mg (as benzoate)
omit:
| STADA Olanzapine | TD | MP NP | C1589 C2044 | 28 | 5 | 28 |
Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)
omit:
| STADA Olanzapine ODT | TD | MP NP | C1589 C2044 | 28 | 5 | 28 |
Schedule 1, after entry for Olmesartan with amlodipine in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine
10 mg (as besylate)
insert:
| Olmesartan with amlodipine and hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg | Oral | Sevikar HCT 20/5/12.5 | MK | MP NP | C4311 | 30 | 5 | 30 |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg | Oral | Sevikar HCT 40/5/12.5 | MK | MP NP | C4311 | 30 | 5 | 30 | |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg | Oral | Sevikar HCT 40/5/25 | MK | MP NP | C4311 | 30 | 5 | 30 | |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg | Oral | Sevikar HCT 40/10/12.5 | MK | MP NP | C4311 | 30 | 5 | 30 | |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg | Oral | Sevikar HCT 40/10/25 | MK | MP NP | C4311 | 30 | 5 | 30 |
Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
(a)omit:
| STADA Pantoprazole | TD | MP NP | C1177 C1337 C1476 C1533 | P1177 | 30 | 2 | 30 |
(b)omit:
| STADA Pantoprazole | TD | MP NP | C1177 C1337 C1476 C1533 | P1337 P1476 P1533 | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| PREXUM 2.5 | RX | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| PREXUM 5 | RX | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| PREXUM 10 | RX | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril arginine 5 mg with indapamide
hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Prexum Combi 5/1.25 | RX | MP NP | C3307 | 30 | 5 | 30 |
Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
omit:
| STADA Quetiapine | TD | MP NP | C1589 C2044 C2765 | 60 | 5 | 60 |
Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
omit:
| STADA Quetiapine | TD | MP NP | C1589 C2044 C2765 | 90 | 5 | 90 |
Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
omit:
| STADA Quetiapine | TD | MP NP | C1589 C2044 C2765 | 60 | 5 | 60 |
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a)omit:
| STADA Rabeprazole | TD | MP NP | C1177 C1337 C1533 | P1177 | 30 | 2 | 30 |
(b)omit:
| STADA Rabeprazole | TD | MP NP | C1177 C1337 C1533 | P1337 P1533 | 30 | 5 | 30 |
Schedule 1, after entry for Rifampicin in the form Syrup 100 mg per 5 mL, 60 mL
insert:
| Rifaximin | Tablet 550 mg | Oral | Xifaxan | NE | MP | C4306 | 56 | 5 | 56 |
Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity 10; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Roxithromycin GH | GQ | PDP | 10 | 0 | 10 |
Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Roxithromycin GH | GQ | MP NP | 10 | 1 | 10 |
Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity 5; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Roxithromycin GH | GQ | PDP | 5 | 0 | 5 |
Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity 5; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Roxithromycin GH | GQ | MP NP | 5 | 1 | 5 |
Schedule 1, entry for Saxagliptin
omit from the column headed “Circumstances”: C3540 substitute: C4350
Schedule 1, entry for Sitagliptin in each of the forms: Tablet 25 mg (as phosphate monohydrate); Tablet 50 mg (as phosphate monohydrate); and Tablet 100 mg (as phosphate monohydrate)
omit from the column headed “Circumstances”: C3540 substitute: C4350
Schedule 1, entry for Sitagliptin with metformin in each of the forms: Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 500 mg metformin hydrochloride; Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 850 mg metformin hydrochloride; and Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”: C3149 C3543 substitute: C4309 C4325
Schedule 1, entry for Sunitinib
substitute:
| Sunitinib | Capsule 12.5 mg (as malate) | Oral | Sutent | PF | MP | C3206 C3207 C4106 C4119 C4341 C4354 | P3206 P3207 P4119 | 28 | 1 | 28 |
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4354 | 28 | 2 | 28 | |||||
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4106 | 28 | 3 | 28 | |||||
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4341 | 28 | 5 | 28 | |||||
| Capsule 25 mg (as malate) | Oral | Sutent | PF | MP | C3206 C3207 C4106 C4119 C4341 C4354 | P3206 P3207 P4119 | 28 | 1 | 28 | |
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4354 | 28 | 2 | 28 | |||||
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4106 | 28 | 3 | 28 | |||||
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4341 | 28 | 5 | 28 | |||||
| Capsule 50 mg (as malate) | Oral | Sutent | PF | MP | C3206 C3207 C4106 C4119 C4341 C4354 | P3206 P3207 P4119 | 28 | 1 | 28 | |
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4354 | 28 | 2 | 28 | |||||
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4106 | 28 | 3 | 28 | |||||
| MP | C3206 C3207 C4106 C4119 C4341 C4354 | P4341 | 28 | 5 | 28 |
Schedule 1, after entry for Terbutaline in the form Injection containing terbutaline sulfate 500 micrograms in 1 mL
insert in the columns in the order indicated:
| Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses | Inhalation by mouth | Bricanyl Turbuhaler | AP | MP NP | 2 | 5 | 1 |
Schedule 1, after entry for Terbutaline in the form Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses
insert:
| Teriflunomide | Tablet 14 mg | Oral | Aubagio | GZ | MP | C4316 C4329 | 28 | 5 | 28 |
Schedule 1, entry for Travoprost with Timolol
substitute:
| Travoprost with timolol | Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Application to the eye | Duotrav | AQ | MP | C4343 | 1 | 5 | 1 |
| AO | C4326 | 1 | 5 | 1 |
Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
omit:
| STADA Venlafaxine‑SR | TD | MP NP | C1211 | 28 | 5 | 28 |
Schedule 1, entry for Vildagliptin
omit from the column headed “Circumstances”: C3540 substitute: C4350
Schedule 1, entry for Vildagliptin with metformin in each of the forms: Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride; Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride; and Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride
omit from the column headed “Circumstances”: C3543 C3686 substitute: C4308 C4325
Schedule 1, entry for Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose in the form Sachets containing oral powder 100 g, 10 (RenaStart)
omit from the column headed “Circumstances”: C1596 substitute: C4322
Schedule 1, after entry for Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose in the form Sachets containing oral powder 100 g, 10 (RenaStart)
insert in the columns in the order indicated:
| Oral powder 400 g, 6 (Renastart) | Oral | Renastart | VF | MP NP | C4322 | 4 | 5 | 1 |
Schedule 1, entry for Ziprasidone in each of the forms: Capsule 20 mg (as hydrochloride); Capsule 40 mg (as hydrochloride);
Capsule 60 mg (as hydrochloride); and Capsule 80 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Ziprasidone | TX | MP NP | C1589 C3084 | 60 | 5 | 60 |
Schedule 3
omit:
| TD | STADA Pharmaceuticals Australia Pty Limited | 73 154 966 944 |
Schedule 4, Part 1, after entry for Alendronic acid with colecalciferol and calcium
insert:
| Alogliptin | C4349 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with alogliptin | Compliance with Authority Required procedures - Streamlined Authority Code 4349 |
Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
insert in numerical order following existing text:
| C4305 | Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae Initial treatment for up to 6 months Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4312 | Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein Initial treatment for up to 6 months Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4323 | Cows' milk protein enteropathy Initial treatment for up to 6 months Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4330 | Cows' milk anaphylaxis Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist; Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4337 | Cows' milk protein enteropathy Continuing treatment Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists; The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4338 | Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae Continuing treatment Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months; The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4339 | Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein Continuing treatment Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4345 | Severe cows' milk protein enteropathy with failure to thrive Continuing treatment Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists; The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4352 | Severe cows' milk protein enteropathy with failure to thrive Initial treatment for up to 6 months Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist; The name of the specialist and the date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Atorvastatin
insert:
| Atorvastatin and ezetimibe | C4068 | Hypercholesterolaemia The treatment must be in conjunction with dietary therapy and exercise Patient must have cholesterol levels that are inadequately controlled with an HMG CoA reductase inhibitor (statin); Inadequate control with a statin is defined as follows: (1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or | Compliance with Authority Required procedures - Streamlined Authority Code 4068 |
| C4069 | Hypercholesterolaemia The treatment must be in conjunction with dietary therapy and exercise; Inadequate control with a statin is defined as follows: (1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or | Compliance with Authority Required procedures - Streamlined Authority Code 4069 | |
| C4085 | Hypercholesterolaemia The treatment must be in conjunction with dietary therapy and exercise; Inadequate control with a statin is defined as follows: (1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or | Compliance with Authority Required procedures - Streamlined Authority Code 4085 | |
| C4086 | Hypercholesterolaemia The treatment must be in conjunction with dietary therapy and exercise; Inadequate control with a statin is defined as follows: (1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or | Compliance with Authority Required procedures - Streamlined Authority Code 4086 | |
| C4096 | Hypercholesterolaemia The treatment must be in conjunction with dietary therapy and exercise; Inadequate control with a statin is defined as follows: (1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or | Compliance with Authority Required procedures - Streamlined Authority Code 4096 | |
| C4097 | Hypercholesterolaemia Patient must have homozygous familial hypercholesterolaemia; | Compliance with Authority Required procedures - Streamlined Authority Code 4097 | |
| C4120 | Hypercholesterolaemia The treatment must be in conjunction with dietary therapy and exercise; Inadequate control with a statin is defined as follows: (1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or | Compliance with Authority Required procedures - Streamlined Authority Code 4120 | |
| C4121 | Hypercholesterolaemia The treatment must be in conjunction with dietary therapy and exercise; Inadequate control with a statin is defined as follows: (1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or | Compliance with Authority Required procedures - Streamlined Authority Code 4121 | |
| C4353 | Hypercholesterolaemia Patient must be eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs); A clinically important product-related adverse event is defined as follows: (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or | Compliance with Authority Required procedures - Streamlined Authority Code 4353 |
Schedule 4, Part 1, entry for Bimatoprost with timolol
substitute:
| Bimatoprost with timolol | C4326 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
| C4343 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
Schedule 4, Part 1, entry for Brimonidine with Timolol
substitute:
| Brimonidine with timolol | C4326 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
| C4343 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
Schedule 4, Part 1, entry for Brinzolamide with timolol
substitute:
| Brinzolamide with timolol | C4326 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
| C4343 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
Schedule 4, Part 1, entry for Budesonide with Eformoterol
insert in numerical order following existing text:
| C4318 | Asthma Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids and have been stabilised on concomitant inhaled eformoterol fumarate and budesonide; OR |
| C4327 | Chronic obstructive pulmonary disease (COPD) Patient must have a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal prior to therapy; |
| C4333 | Asthma Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids and have been stabilised on concomitant inhaled eformoterol fumarate and budesonide |
Schedule 4, Part 1, after entry for Calcium
insert:
| Canagliflozin | C4321 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Dabigatran etexilate
insert:
| Dabrafenib | C4317 | P4317 | Unresectable Stage III or Stage IV malignant melanoma Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; | Compliance with Authority Required procedures |
| C4340 | P4340 | Unresectable Stage III or Stage IV malignant melanoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Dantrolene
insert:
| Dapagliflozin | C4331 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Darunavir
(a)omit:
| C3940 | Where the patient is receiving treatment at/from a Private Hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing | Compliance with Written or Telephone Authority Required procedures |
| C3941 | Where the patient is receiving treatment at/from a Public Hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3941 |
(b)insert in numerical order following existing text:
| C4313 | Human immunodeficiency virus (HIV) infection The treatment must be in addition to optimised background therapy; Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4313 |
| C4346 | Human immunodeficiency virus (HIV) infection The treatment must be in addition to optimised background therapy; Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity | Compliance with Written and Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Denosumab
(a)omit:
| C4094 | Osteoporosis Patient must be female; Patient must be aged 70 years or older; Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 4094 |
| C4145 | Established post-menopausal osteoporosis Patient must have fracture due to minimal trauma; Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 4145 |
(b)insert in numerical order following existing text:
| C4314 | Osteoporosis Patient must be aged 70 years or older; The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 4314 |
| C4347 | Established osteoporosis Patient must have fracture due to minimal trauma; The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | Compliance with Authority Required procedures - Streamlined Authority Code 4347 |
Schedule 4, Part 1, after entry for Didanosine
insert:
| Dimethyl fumarate | C4320 | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application | Compliance with Authority Required procedures |
| C4335 | Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application | Compliance with Authority Required procedures | |
| C4356 | Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Dorzolamide with Timolol
substitute:
| Dorzolamide with timolol | C4326 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
| C4343 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
Schedule 4, Part 1, entry for Everolimus
insert in numerical order following existing text:
| C4334 | Tuberous sclerosis complex (TSC) Continuing treatment The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; OR | Compliance with Authority Required procedures |
| C4351 | Tuberous sclerosis complex (TSC) Initial treatment The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; OR | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Flutamide
insert:
| Fluticasone with eformoterol | C4315 | Asthma Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids |
Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
[Circumstances Code C4253]
omit from the column headed “Circumstances and Purposes”:
KetoCal 3:1 should only be used under strict supervision of a dietician, together with a metabolic physician and/or neurologist
substitute:
KetoCal 3:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist
Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
[Circumstances Code C4289]
omit from the column headed “Circumstances and Purposes”:
KetoCal 4:1 should only be used under strict supervision of a dietician, together with a metabolic physician and/or neurologist
substitute:
KetoCal 4:1 should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist
Schedule 4, Part 1, omit entry for Ifosfamide
Schedule 4, Part 1, entry for Imatinib
(a)omit:
| C3847 | P3847 | Resectable gastrointestinal stromal tumour Adjuvant treatment of a patient at high risk of recurrence following complete resection of primary gastrointestinal stromal tumour (GIST) which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, at a dose not exceeding 400 mg per day for a period of 12 months. High risk of recurrence is defined as: Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or Primary GIST greater than 10 cm with any mitotic rate; or Primary GIST with a mitotic count of greater than 10/50 HPF. Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following: (i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and (ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application | Compliance with Written Authority Required procedures |
| C3848 | P3848 | Resectable gastrointestinal stromal tumour Initial treatment of a patient who was receiving adjuvant imatinib mesylate for gastrointestinal stromal tumour (GIST) prior to 1 September 2011 and who meets the PBS eligibility criteria for adjuvant treatment with imatinib mesylate of a patient at high risk of recurrence following complete resection of primary GIST. The patient is eligible to receive sufficient imatinib at a dose of 400 mg per day to complete 12 months of combined PBS-subsidised and non-PBS-subsidised therapy. Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following: (i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and (ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented | Compliance with Written Authority Required procedures |
(b)insert in numerical order following existing text:
| C4342 | P4342 | Gastrointestinal stromal tumour Continuing treatment The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); Applications for continuing therapy may be made by telephone | Compliance with Written or Telephone Authority Required procedures |
| C4355 | P4355 | Gastrointestinal stromal tumour Initial treatment The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); Applications for authorisation of initial treatment must be in writing and must include: (1) a completed authority prescription form; and High risk of recurrence is defined as: | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, after entry for Insulin Detemir
insert:
| Insulin Isophane | C4332 | Diabetes mellitus Patient must be intolerant to human insulin | Compliance with Authority Required procedures |
| Insulin Neutral | C4332 | Diabetes mellitus Patient must be intolerant to human insulin | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Itraconazole
insert:
| Ivabradine | C4310 | Chronic heart failure Patient must be symptomatic with NYHA classes II or III; Resting heart rate should be measured by ECG after 5 minutes rest The ECG result must be documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Ivermectin
substitute:
| Ivermectin | C4319 | P4319 | Onchocerciasis | Compliance with Authority Required procedures - Streamlined Authority Code 4319 |
| C4328 | P4328 | Strongyloidiasis | Compliance with Authority Required procedures - Streamlined Authority Code 4328 |
Schedule 4, Part 1, entry for Ketoconazole
omit:
| C3604 | P3604 | Oral candidiasis in severely immunocompromised persons where topical therapy has failed | Compliance with Authority Required procedures - Streamlined Authority Code 3604 |
| C3605 | P3605 | Systemic or deep mycoses where other forms of therapy have failed | Compliance with Authority Required procedures - Streamlined Authority Code 3605 |
| C3606 | P3606 | Symptomatic genital candidiasis recurring after treatment of at least 2 episodes with topical therapy | Compliance with Authority Required procedures - Streamlined Authority Code 3606 |
Schedule 4, Part 1, entry for Latanoprost with Timolol
substitute:
| Latanoprost with timolol | C4326 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
| C4343 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
Schedule 4, Part 1, entry for Linagliptin
substitute:
| Linagliptin | C4350 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4350 |
Schedule 4, Part 1, entry for Milk powder—lactose free formula
insert in numerical order following existing text:
| C4324 | P4324 | Acute lactose intolerance Patient must be up to the age of 12 months The date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
| C4336 | P4336 | Chronic lactose intolerance Patient must be up to the age of 12 months; (a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or The date of birth of the patient must be included in the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Nicotine
substitute:
| Nicotine | C4307 | Nicotine dependence The treatment must be the sole PBS-subsidised therapy for this condition; Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 4307 |
| C4344 | Nicotine dependence Patient must be an Aboriginal or a Torres Strait Islander person; | Compliance with Authority Required procedures - Streamlined Authority Code 4344 | |
| C4348 | Nicotine dependence The treatment must be the sole PBS-subsidised therapy for this condition; Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 4348 |
Schedule 4, Part 1, after entry for Olmesartan with amlodipine
insert:
| Olmesartan with amlodipine and hydrochlorothiazide | C4311 | Hypertension The treatment must not be for the initiation of anti-hypertensive therapy; |
Schedule 4, Part 1, after entry for Rifampicin
insert:
| Rifaximin | C4306 | Prevention of hepatic encephalopathy Must be treated by a gastroenterologist or hepatologist or in consultation with a gastroenterologist or hepatologist; | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Saxagliptin
substitute:
| Saxagliptin | C4350 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4350 |
Schedule 4, Part 1, entry for Sitagliptin
substitute:
| Sitagliptin | C4350 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4350 |
Schedule 4, Part 1, entry for Sitagliptin with metformin
substitute:
| Sitagliptin with metformin | C4309 | Diabetes mellitus type 2 Continuing treatment Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin | Compliance with Authority Required procedures - Streamlined Authority Code 4309 |
| C4325 | Diabetes mellitus type 2 Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4325 |
Schedule 4, Part 1, entry for Sunitinib
insert in numerical order following existing text:
| C4341 | P4341 | Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) Continuing treatment Patient must have previously been issued with an authority prescription for sunitinib; | Compliance with Authority Required procedures |
| C4354 | P4354 | Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) Initial treatment Patient must be symptomatic (despite somatostatin analogues); OR Disease progression must be documented in the patient's medical records | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Terbinafine
insert:
| Teriflunomide | C4316 | Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application | Compliance with Authority Required procedures |
| C4329 | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Travoprost with Timolol
substitute:
| Travoprost with timolol | C4326 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
| C4343 | Elevated intra-ocular pressure The condition must have been inadequately controlled with monotherapy; |
Schedule 4, Part 1, entry for Vildagliptin
substitute:
| Vildagliptin | C4350 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: (a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4350 |
Schedule 4, Part 1, entry for Vildagliptin with metformin
substitute:
| Vildagliptin with metformin | C4308 | Diabetes mellitus type 2 Continuing treatment Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and vildagliptin | Compliance with Authority Required procedures - Streamlined Authority Code 4308 |
| C4325 | Diabetes mellitus type 2 Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4325 |
Schedule 4, Part 1, entry for Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose
substitute:
| Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | C4322 | Chronic renal failure Patient must be an infant or a young child; | Compliance with Authority Required procedures |
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