National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 10) (PB 92 of 2017) (Cth)
PB 92 of 2017
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 10)
National Health Act 1953
I, LISA LA RANCE, Assistant Secretary, Pricing and Policy Branch, Technology Assessment and Access 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 28th November 2017
LISA LA RANCE
Assistant Secretary
Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 10).
(2) This Instrument may also be cited as PB 92 of 2017.
2 Commencement
This Instrument commences on 1 December 2017.
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 Abiraterone in the form Tablet containing abiraterone acetate 250 mg
insert:
| Tablet containing abiraterone acetate 500 mg | Oral | Zytiga | JC | MP | C6944 | 60 | 2 | 60 |
Schedule 1, entry for Allopurinol in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Allopurinol APOTEX | GX | MP NP | 200 | 2 | 200 |
Schedule 1, entry for Allopurinol in the form Tablet 300 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Allopurinol APOTEX | GX | MP NP | 60 | 2 | 60 |
(b)insert in the column headed “Schedule Equivalent” for all brands: a
Schedule 1, entry for Alprazolam in the form Tablet 250 micrograms
omit:
| a | Alprax 0.25 | QA | MP NP | C6773 | 10 | 0 | 50 |
| a | Kalma 0.25 | AF | MP NP | C6773 | 10 | 0 | 50 |
substitute:
| a | Kalma 0.25 | AF | MP NP | C6773 | 10 | 0 | 10 |
| MP NP | C6773 | 10 | 0 | 50 | |||
| a | Alprax 0.25 | QA | MP NP | C6773 | 10 | 0 | 50 |
Schedule 1, entry for Alprazolam in the form Tablet 500 micrograms
omit:
| a | Kalma 0.5 | AF | MP NP | C6773 | 10 | 0 | 50 |
substitute:
| a | Kalma 0.5 | AF | MP NP | C6773 | 10 | 0 | 10 |
| MP NP | C6773 | 10 | 0 | 50 |
Schedule 1, entry for Alprazolam in the form Tablet 1 mg
omit:
| a | Kalma 1 | AF | MP NP | C6773 | 10 | 0 | 50 |
substitute:
| a | Kalma 1 | AF | MP NP | C6773 | 10 | 0 | 10 |
| MP NP | C6773 | 10 | 0 | 50 |
Schedule 1, entry for Amisulpride in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Amisulpride | CR | MP NP | C4246 | 30 | 5 | 30 |
Schedule 1, entry for Amisulpride in each of the forms: Tablet 200 mg; and Tablet 400 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Amisulpride | CR | MP NP | C4246 | 60 | 5 | 60 |
Schedule 1, entry for Amoxycillin in each of the forms: Capsule 250 mg (as trihydrate); and Capsule 500 mg (as trihydrate)
(a)omit:
| Chem mart Amoxycillin | CH | PDP | 20 | 0 | 20 |
(b)omit:
| Terry White Chemists Amoxycillin | TW | PDP | 20 | 0 | 20 |
(c)omit:
| Chem mart Amoxycillin | CH | MP NP MW | 20 | 1 | 20 |
(d)omit:
| Terry White Chemists Amoxycillin | TW | MP NP MW | 20 | 1 | 20 |
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | AMOXICLAV AMNEAL 500/125 | ED | PDP | C5833 C5894 | 10 | 0 | 10 |
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | AMOXICLAV AMNEAL 500/125 | ED | MP NP MW | C5832 C5893 | 10 | 1 | 10 |
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | AMOXICLAV AMNEAL 875/125 | ED | PDP | C5833 C5894 | 10 | 0 | 10 |
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | AMOXICLAV AMNEAL 875/125 | ED | MP NP | C5832 C5893 | 10 | 1 | 10 |
Schedule 1, entry for Apomorphine
omit:
| Injection containing apomorphine hydrochloride 10 mg in 1 mL | Injection | Apomine | PF | MP | C4833 C4860 | 360 | 5 | 5 | D(100) |
Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Atorvastatin | CR | MP | C4238 C4263 | P4263 | 30 | 5 | 30 |
| NP | C4263 | 30 | 5 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Atorvastatin | CR | MP | C4238 C4263 | P4238 | 30 | 11 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Atorvastatin | CR | MP | C4238 C4263 | P4263 | 30 | 5 | 30 |
| NP | C4263 | 30 | 5 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Atorvastatin | CR | MP | C4238 C4263 | P4238 | 30 | 11 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Atorvastatin | CR | MP | C4238 C4263 | P4263 | 30 | 5 | 30 |
| NP | C4263 | 30 | 5 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Atorvastatin | CR | MP | C4238 C4263 | P4238 | 30 | 11 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Atorvastatin | CR | MP | C4238 C4263 | P4263 | 30 | 5 | 30 |
| NP | C4263 | 30 | 5 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pharmacor Atorvastatin | CR | MP | C4238 C4263 | P4238 | 30 | 11 | 30 |
Schedule 1, entry for Auranofin in the form Tablet 3 mg
omit:
| MP NP | 100 | 3 | 100 |
Schedule 1, entry for Baclofen in each of the forms: Tablet 10 mg; and Tablet 25 mg
(a)omit:
| a | Chem mart Baclofen | CH | MP NP | 100 | 5 | 100 |
(b)omit:
| a | Terry White Chemists Baclofen | TW | MP NP | 100 | 5 | 100 |
Schedule 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Bimtop | QA | MP AO | 1 | 5 | 1 |
Schedule 1, entry for Bosentan in each of the forms: Tablet 62.5 mg (as monohydrate); and Tablet 125 mg (as monohydrate)
omit:
| a | APO-BOSENTAN | GX | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 60 | D(100) |
Schedule 1, entry for Brentuximab vedotin
omit from the column headed “Circumstances”: C4719
insert in numerical order in the column headed “Circumstances”: C7244
Schedule 1, entry for Cephalexin in the form Granules for oral suspension 125 mg per 5 mL, 100 mL
(a)omit:
| APO‑Cephalexin | TX | PDP | 1 | 0 | 1 |
(b)omit:
| Chem mart Cephalexin | CH | PDP | 1 | 0 | 1 |
(c)omit:
| Terry White Chemists Cephalexin | TW | PDP | 1 | 0 | 1 |
(d)omit:
| APO‑Cephalexin | TX | MP NP | 1 | 1 | 1 |
(e)omit:
| Chem mart Cephalexin | CH | MP NP | 1 | 1 | 1 |
(f)omit:
| Terry White Chemists Cephalexin | TW | MP NP | 1 | 1 | 1 |
Schedule 1, entry for Cephalexin in the form Granules for oral suspension 250 mg per 5 mL, 100 mL
(a)omit:
| APO‑Cephalexin | TX | PDP | 1 | 0 | 1 |
(b)omit:
| Chem mart Cephalexin | CH | PDP | 1 | 0 | 1 |
(c)omit:
| Terry White Chemists Cephalexin | TW | PDP | 1 | 0 | 1 |
(d)omit:
| APO‑Cephalexin | TX | MP NP | 1 | 1 | 1 |
(e)omit:
| Chem mart Cephalexin | CH | MP NP | 1 | 1 | 1 |
(f)omit:
| Terry White Chemists Cephalexin | TW | MP NP | 1 | 1 | 1 |
Schedule 1, entry for Clindamycin
omit from the column headed “Responsible Person” for the brand “Clindamycin-Link” (twice occurring): LM substitute: LI
Schedule 1, entry for Dutasteride
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Dutasteride | TX | MP NP | C6202 | 30 | 5 | 30 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Avodart”: a
Schedule 1, entry for Epoetin Lambda in all forms
(a)omit from the column headed “Listed Drug”: Epoetin Lambda substitute: Epoetin lambda
(b)omit from the column headed “Circumstances”: C6245 C6261 substitute: C6260 C6294
Schedule 1, entry for Eribulin
insert in numerical order in the column headed “Circumstances”: C7258 C7280
Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Escitalopram Sandoz | HX | MP NP | C4755 | 28 | 5 | 28 |
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit all codes from the column headed “Circumstances”, substitute:
C6808 C6836 C7168 C7174 C7177 C7179 C7181 C7205 C7209 C7217 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7264 C7276 C7288 C7289 C7296 C7300 C7308 C7309 C7317 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P6808 P6836 P7177 P7205 P7209 P7220 P7221 P7224 P7235 P7237 P7288 P7308 P7309 P7336
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit all codes from the column headed “Circumstances”, substitute:
C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7169 C7170 C7174 C7177 C7179 C7180 C7181 C7205 C7209 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7251 C7264 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7205 P7209 P7220 P7221 P7224 P7235 P7237 P7288 P7308 P7309 P7336
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit all codes from the column headed “Circumstances”, substitute:
C6808 C6836 C7168 C7174 C7177 C7179 C7181 C7205 C7209 C7217 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7264 C7276 C7288 C7289 C7296 C7300 C7308 C7309 C7317 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P7168 P7174 P7179 P7181 P7217 P7219 P7222 P7264 P7276 P7289 P7296 P7300 P7317 P7320
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit all codes from the column headed “Circumstances”, substitute:
C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7169 C7170 C7174 C7177 C7179 C7180 C7181 C7205 C7209 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7251 C7264 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P4457 P4482 P7169 P7170 P7174 P7179 P7180 P7181 P7219 P7222 P7251 P7264 P7287 P7289 P7300 P7307 P7320
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys;
Maximum Quantity: 1; Number of Repeats: 3]
(a)omit all codes from the column headed “Circumstances”, substitute:
C6808 C6836 C7168 C7174 C7177 C7179 C7181 C7205 C7209 C7217 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7264 C7276 C7288 C7289 C7296 C7300 C7308 C7309 C7317 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P6808 P6836 P7177 P7205 P7209 P7220 P7221 P7224 P7235 P7237 P7288 P7308 P7309 P7336
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit all codes from the column headed “Circumstances”, substitute:
C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7169 C7170 C7174 C7177 C7179 C7180 C7181 C7205 C7209 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7251 C7264 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7205 P7209 P7220 P7221 P7224 P7235 P7237 P7288 P7308 P7309 P7336
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys;
Maximum Quantity: 1; Number of Repeats: 5]
(a)omit all codes from the column headed “Circumstances”, substitute:
C6808 C6836 C7168 C7174 C7177 C7179 C7181 C7205 C7209 C7217 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7264 C7276 C7288 C7289 C7296 C7300 C7308 C7309 C7317 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P7168 P7174 P7179 P7181 P7217 P7219 P7222 P7264 P7276 P7289 P7296 P7300 P7317 P7320
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit all codes from the column headed “Circumstances”, substitute:
C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7169 C7170 C7174 C7177 C7179 C7180 C7181 C7205 C7209 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7251 C7264 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P4457 P4482 P7169 P7170 P7174 P7179 P7180 P7181 P7219 P7222 P7251 P7264 P7287 P7289 P7300 P7307 P7320
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit all codes from the column headed “Circumstances”, substitute:
C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7169 C7170 C7174 C7177 C7179 C7180 C7181 C7205 C7209 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7251 C7264 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P4458 P4483 P4503 P6808 P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6836 P6843 P7177 P7205 P7209 P7220 P7221 P7224 P7235 P7237 P7288 P7308 P7309 P7336
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit all codes from the column headed “Circumstances”, substitute:
C4457 C4458 C4482 C4483 C4503 C6808 C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6836 C6843 C7169 C7170 C7174 C7177 C7179 C7180 C7181 C7205 C7209 C7219 C7220 C7221 C7222 C7224 C7235 C7237 C7251 C7264 C7287 C7288 C7289 C7300 C7307 C7308 C7309 C7320 C7336
(b)omit all codes from the column headed “Purposes”, substitute:
P4457 P4482 P7169 P7170 P7174 P7179 P7180 P7181 P7219 P7222 P7251 P7264 P7287 P7289 P7300 P7307 P7320
Schedule 1, entry for Etoposide
omit:
| Powder for I.V. infusion 100 mg (as phosphate) | Injection | Etopophos | BQ | MP | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, entry for Evolocumab in the form Injection 140 mg in 1 mL single use pre-filled pen
omit from the column headed “Circumstances”: C6586
insert in numerical order in the column headed “Circumstances”: C7329
Schedule 1, omit entry for Foscarnet
Schedule 1, entry for Gabapentin in each of the forms: Capsule 300 mg; Capsule 400 mg; Tablet 600 mg; and Tablet 800 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Gabapentin | TX | MP NP | C4928 | 100 | 5 | 100 |
Schedule 1, entry for Goserelin in the form Subcutaneous implant 3.6 mg (as acetate) in pre filled injection syringe
insert in numerical order in the column headed “Circumstances”: C7164
Schedule 1, entry for Hydroxocobalamin in the form Injection 1 mg (as acetate) in 1 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Cobal-B12 | JU | MP NP | C5840 C5841 C5854 | 3 | 0 | 3 |
Schedule 1, entry for Hyoscine
(a)insert in the column headed “Schedule Equivalent” for the brand “Buscopan”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | HYOSCINE BUTYLBROMIDE SXP | XC | MP NP | C6207 | 30 | 3 | 5 |
Schedule 1, after entry for Ibandronic acid in the form Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in 6 mL
insert:
| Ibrutinib | Capsule 140 mg | Oral | Imbruvica | JC | MP | C7260 C7337 | 90 | 5 | 90 |
Schedule 1, entry for Icatibant
omit from the column headed “Circumstances”: C4917 C4949 substitute:C7273 C7274
Schedule 1, entry for Idelalisib in each of the forms: Tablet 100 mg; and Tablet 150 mg
omit from the column headed “Circumstances”: C7051
insert in numerical order in the column headed “Circumstances”: C7310
Schedule 1, entry for Isotretinoin in the form Capsule 10 mg
omit:
| Roaccutane | RO | MP | C5224 | 60 | 3 | 60 |
Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; and Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Sandoz Lamotrigine | HX | MP NP | C5138 | 56 | 5 | 56 |
Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg
omit:
| a | APO‑Leflunomide | TX | MP | C5681 | 30 | 5 | 30 |
Schedule 1, after entry for Mesalazine in the form Tablet 500 mg (prolonged release)
insert:
| Tablet 800 mg (enteric coated) | Oral | Asacol | EU | MP NP | C4824 | 180 | 5 | 90 |
Schedule 1, entry for Milk powder—lactose free formula
omit:
| Oral powder 900 g (S‑26 LF) | Oral | S‑26 LF | AS | MP NP | C4324 C4336 | P4324 | 5 | 0 | 1 |
| MP NP | C4324 C4336 | P4336 | 5 | 5 | 1 | ||||
| Oral powder 900 g (Aptamil Gold+ De-Lact) | Oral | Aptamil Gold+ De-Lact | NU | MP NP | C4324 C4336 | P4324 | 5 | 0 | 1 |
| MP NP | C4324 C4336 | P4336 | 5 | 5 | 1 |
substitute:
| Oral powder 900 g (Aptamil Gold+ De-Lact) | Oral | Aptamil Gold+ De-Lact | NU | MP NP | C7198 | 5 | 0 | 1 |
| Oral powder 900 g (S-26 LF) | Oral | S-26 LF | AS | MP NP | C4324 | 5 | 0 | 1 |
Schedule 1, after entry for Milk powder—lactose free formula in the form Oral powder 900 g (S-26 LF)
insert:
| Milk powder lactose intolerance formula | Oral powder 900 g (S-26 Original LI) | Oral | S-26 Original LI | AS | MP NP | C7257 | 5 | 0 | 1 |
Schedule 1, entry for Mirtazapine in the form Tablet 45 mg
omit:
| a | Avanza | MK | MP NP | C5650 | 30 | 5 | 30 |
Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| PRYZEX | RW | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| PRYZEX ODT | RW | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); Powder for I.V. infusion 500 mg
(as disodium); and Powder for I.V. infusion 1 g (as disodium)
omit from the column headed “Circumstances” (all instances): C4789
insert in numerical order in the column headed “Circumstances” (all instances): C7195
Schedule 1, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Salbutamol AN | JU | MP NP | C6815 C6825 | 2 | 5 | 1 |
Schedule 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Salbutamol AN | JU | MP NP | C6815 C6825 | 2 | 5 | 1 |
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 2]
omit from the column headed “Circumstances”: C6437
omit from the column headed “Circumstances”: C6467
omit from the column headed “Circumstances”: C6483
omit from the column headed “Circumstances”: C6485 C6486 C6487
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
omit from the column headed “Circumstances”: C6437
omit from the column headed “Circumstances”: C6467
omit from the column headed “Circumstances”: C6483
omit from the column headed “Circumstances”: C6485 C6486 C6487
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C6437
omit from the column headed “Circumstances”: C6467
omit from the column headed “Circumstances”: C6483
omit from the column headed “Circumstances”: C6485 C6486 C6487
(b)omit from the column headed “Purposes”: P6487 substitute: P6415
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C6437
omit from the column headed “Circumstances”: C6467
omit from the column headed “Circumstances”: C6483
omit from the column headed “Circumstances”: C6485 C6486 C6487
(b)omit from the column headed “Purposes”: P6483 P6485 P6486 substitute: P6427 P6438 P6439
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C6437
omit from the column headed “Circumstances”: C6467
omit from the column headed “Circumstances”: C6483
omit from the column headed “Circumstances”: C6485 C6486 C6487
(b)omit from the column headed “Purposes”: P6437
omit from the column headed “Purposes”: P6467
insert in numerical order in the column headed “Purposes”: P6482 P6484
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 8; Number of Repeats: 0]
omit from the column headed “Circumstances”: C6437
omit from the column headed “Circumstances”: C6467
omit from the column headed “Circumstances”: C6483
omit from the column headed “Circumstances”: C6485 C6486 C6487
Schedule 1, entry for Telmisartan in each of the forms: Tablet 40 mg; and Tablet 80 mg
(a)omit:
| Chem mart Telmisartan | CH | MP NP | 28 | 5 | 28 |
(b)omit:
| Terry White Chemists Telmisartan | TW | MP NP | 28 | 5 | 28 |
Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Terbinafine | TX | MP NP | C6395 C6404 C6453 | P6404 P6453 | 42 | 0 | 42 |
(b)insert in the column headed “Schedule Equivalent” for all brands: a
Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 1]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Terbinafine | TX | MP NP | C6395 C6404 C6453 | P6395 | 42 | 1 | 42 |
(b)insert in the column headed “Schedule Equivalent” for all brands: a
Schedule 1, after entry for Vismodegib
insert:
| Vitamins, minerals and trace elements formula | Sachets containing oral powder 7 g, 30 (Phlexy-Vits) | Oral | Phlexy-Vits | SB | MP NP | C7275 | 1 | 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)
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | ZIPROX | RW | MP NP | C4246 C5742 | 60 | 5 | 60 |
Schedule 3, details relevant to Responsible Person code BX
omit from the column headed “Responsible Person”: Baxter Healthcare Pty Ltd substitute: Baxter Healthcare Pty Limited
Schedule 3, details relevant to Responsible Person code FK
omit from the column headed “Responsible Person”: A.Menarini Australia Pty Ltd substitute: A. Menarini Australia Pty Limited
Schedule 3, after details relevant to Responsible Person code KY
insert:
| LI | Luminarie Pty Ltd | 18 601 868 375 |
Schedule 3
omit:
| MI | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 3, details relevant to Responsible Person code NE
omit from the column headed “Responsible Person”: Norgine Pty Ltd substitute: Norgine Pty Limited
Schedule 3
(a)omit:
| OY | Orion Laboratories Pty Ltd | 56 009 293 136 |
(b)omit:
| TE | Takeda Pharmaceuticals Australia Pty Ltd | 71 095 610 870 |
Schedule 3, after details relevant to Responsible Person code XA
insert:
| XC | Southern Cross Pharma Pty Ltd | 47 094 447 677 |
Schedule 4, Part 1, entry for Brentuximab vedotin
(a)omit:
| C4719 | CD30 positive systemic anaplastic large cell lymphoma Initial treatment The treatment must be for curative intent; AND Applications for authorisation of initial treatment must be in writing and must include: A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C7244 | CD30 positive systemic anaplastic large cell lymphoma Initial treatment The treatment must be for curative intent; AND Applications for authorisation of initial treatment must be in writing and must include: A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Epoetin lambda
substitute:
| C6260 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND | Compliance with Authority Required procedures |
| C6294 | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND | Compliance with Authority Required procedures - Streamlined Authority Code 6294 |
Schedule 4, Part 1, entry for Eribulin
insert in numerical order after existing text:
| C7258 | Advanced (unresectable and/or metastatic) liposarcoma Initial treatment Patient must have an ECOG performance status of 2 or less; AND | Compliance with Authority Required procedures - Streamlined Authority Code 7258 |
| C7280 | Advanced (unresectable and/or metastatic) liposarcoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND | Compliance with Authority Required procedures - Streamlined Authority Code 7280 |
Schedule 4, Part 1, entry for Etanercept
(a)omit:
| C4610 | P4610 | Ankylosing spondylitis Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply Patient must have active, or a documented history of active, ankylosing spondylitis; AND Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions Patient must be an adult Must be treated by a rheumatologist | Compliance with Authority Required procedures |
| C4643 | P4643 | Ankylosing spondylitis Continuing treatment – balance of supply Patient must have a documented history of active ankylosing spondylitis; AND Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction Patient must be an adult Must be treated by a rheumatologist | Compliance with Authority Required procedures |
| C4676 | P4676 | Severe active rheumatoid arthritis Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND Must be treated by a rheumatologist; OR | Compliance with Authority Required procedures |
| C4766 | P4766 | Severe active rheumatoid arthritis Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR Must be treated by a rheumatologist; OR | Compliance with Authority Required procedures |
| C4845 | P4845 | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND Must be treated by a rheumatologist; OR | Compliance with Authority Required procedures |
| C4851 | P4851 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Must be treated by a rheumatologist; OR | Compliance with Authority Required procedures |
| C6423 | P6423 | Ankylosing spondylitis Continuing treatment Patient must have a documented history of active ankylosing spondylitis; AND All measurements provided must be no more than 1 month old at the time of application. Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures |
| C6430 | P6430 | Ankylosing spondylitis Initial 2 (change or recommencement for all patients) Patient must have a documented history of active ankylosing spondylitis; AND Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. The authority application must be made in writing and must include: Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures |
| C6437 | P6437 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. | Compliance with Written Authority Required procedures |
| C6439 | P6439 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications. All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course. Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. | Compliance with Written Authority Required procedures |
| C6445 | P6445 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be an adult. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug. Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased. Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). | Compliance with Written Authority Required procedures |
| C6458 | P6458 | Active ankylosing spondylitis Initial 1 (new patients) The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or secukinumab in this treatment cycle; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months. Patient must be an adult. Must be treated by a rheumatologist. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application. Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a completed BASDAI Assessment Form; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) a signed patient acknowledgment. The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle. | Compliance with Written Authority Required procedures |
| C6807 | P6807 | Severe chronic plaque psoriasis Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR | Compliance with Authority Required procedures |
(b)omit:
| C6821 | P6821 | Severe chronic plaque psoriasis Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR | Compliance with Authority Required procedures |
(c)omit:
| C6833 | P6833 | Severe active rheumatoid arthritis Continuing treatment Patient must have a documented history of severe active rheumatoid arthritis; AND | Compliance with Written Authority Required procedures |
| C6834 | P6834 | Severe chronic plaque psoriasis Initial treatment – Initial 2, Whole body (change or recommencement of treatment after a break of less than 5 years) Patient must have a documented history of severe chronic plaque psoriasis; AND | Compliance with Written Authority Required procedures |
(d)omit:
| C6837 | P6837 | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Patient must have severe active rheumatoid arthritis; AND | Compliance with Written Authority Required procedures |
| C6840 | P6840 | Severe chronic plaque psoriasis Continuing treatment, Face, hand, foot Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND | Compliance with Written Authority Required procedures |
| C6841 | P6841 | Severe chronic plaque psoriasis Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment after a break of less than 5 years) Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND | Compliance with Written Authority Required procedures |
| C6842 | P6842 | Severe chronic plaque psoriasis Continuing treatment, Whole body Patient must have a documented history of severe chronic plaque psoriasis; AND | Compliance with Written Authority Required procedures |
(e)omit:
| C6844 | P6844 | Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months) Patient must have a documented history of severe active rheumatoid arthritis; AND | Compliance with Written Authority Required procedures |
(f)insert in numerical order after existing text:
| C7168 | P7168 | Active ankylosing spondylitis Subsequent continuing treatment Must be treated by a rheumatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 7168 |
| C7169 | P7169 | Active ankylosing spondylitis Continuing treatment – balance of supply Must be treated by a rheumatologist. | Compliance with Authority Required procedures |
| C7170 | P7170 | Active ankylosing spondylitis Subsequent continuing treatment Must be treated by a rheumatologist. | Compliance with Written Authority Required procedures |
| C7174 | P7174 | Ankylosing spondylitis First continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND | Compliance with Written Authority Required procedures |
| C7177 | P7177 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment after a break of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR | Compliance with Authority Required procedures |
| C7179 | P7179 | Severe active rheumatoid arthritis Continuing treatment – balance of supply Must be treated by a rheumatologist; OR | Compliance with Authority Required procedures |
| C7180 | P7180 | Severe active rheumatoid arthritis Subsequent continuing treatment Must be treated by a rheumatologist; OR | Compliance with Written Authority Required procedures |
| C7181 | P7181 | Severe psoriatic arthritis First continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND | Compliance with Written Authority Required procedures |
| C7205 | P7205 | Ankylosing spondylitis Initial treatment– Initial 1 (new patients or recommencement of treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment after a break of less than 5 years) – balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or recommencement of treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR | Compliance with Authority Required procedures |
| C7209 | P7209 | Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months) Must be treated by a rheumatologist; OR | Compliance with Written Authority Required procedures |
| C7217 | P7217 | Severe psoriatic arthritis Subsequent continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND | Compliance with Authority Required procedures - Streamlined Authority Code 7217 |
| C7219 | P7219 | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR | Compliance with Authority Required procedures |
| C7220 | P7220 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment after a break of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND | Compliance with Written Authority Required procedures |
| C7221 | P7221 | Ankylosing spondylitis Initial 2 (change or recommencement of treatment after a break of less than 5 years) Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND | Compliance with Written Authority Required procedures |
| C7222 | P7222 | Severe active rheumatoid arthritis First Continuing treatment Must be treated by a rheumatologist; OR | Compliance with Written Authority Required procedures |
| C7224 | P7224 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR | Compliance with Written Authority Required procedures |
| C7235 | P7235 | Active ankylosing spondylitis Initial 1 (new patients or recommencement of treatment after a break of 5 years or more) The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND |
Schedule 4, Part 1, entry for Evolocumab
(a)omit:
| C6586 | Familial homozygous hypercholesterolaemia Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre after at least 3 months of treatment at a maximum tolerated dose of an HMG CoA reductase inhibitor (statin), in conjunction with dietary therapy and exercise, prior to initiation of treatment with this drug; OR Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre after having developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a withdrawal of statin treatment, prior to initiation of treatment with this drug; OR Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre prior to initiation of treatment with this drug, and must be contraindicated to treatment with an HMG CoA reductase inhibitor (statin). Must be treated by a consultant physician or in consultation with a consultant physician. The date of the consultation with a consultant physician must be no more than 6 months prior to the application for a PBS authority. The full name of the consultant physician consulted and the date of consultation are to be provided at the time of application. The qualifying LDL cholesterol level prior to initiation of treatment with this drug must be provided at the time of application. With the exception of patients contraindicated to a statin, the agent, dose and duration of statin treatment must be provided at the time of application. 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 (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. The authority application must be made in writing and must include: a) A completed authority prescription form; and b) A completed Familial homozygous hypercholesterolaemia Initial PBS 'Grandfather' Authority Application - Supporting Information Form; and c) The date of consultation and the full name of the consultant physician; and d) A copy of the qualifying Dutch Lipid Clinic Network Score or a copy of the result of genetic testing; and e) The result of LDL cholesterol level and one of the following where appropriate: statin treatment details including agent, dose and treatment duration; or details of adverse event or contraindication to treatment with a statin as defined in the TGA-approved Product Information. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C7329 | Familial homozygous hypercholesterolaemia Grandfathering treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2016; AND The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre after at least 3 months of treatment at a maximum tolerated dose of an HMG CoA reductase inhibitor (statin), in conjunction with dietary therapy and exercise, prior to initiation of treatment with this drug; OR Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre after having developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a withdrawal of statin treatment, prior to initiation of treatment with this drug; OR Patient must have had an LDL cholesterol level in excess of 3.3 millimoles per litre prior to initiation of treatment with this drug, and must be contraindicated to treatment with an HMG CoA reductase inhibitor (statin). Must be treated by a consultant physician or in consultation with a consultant physician. The date of the consultation with a consultant physician must be no more than 6 months prior to the application for a PBS authority. The full name of the consultant physician consulted and the date of consultation are to be provided at the time of application. The qualifying LDL cholesterol level prior to initiation of treatment with this drug must be provided at the time of application. With the exception of patients contraindicated to a statin, the agent, dose and duration of statin treatment must be provided at the time of application. 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 (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. The authority application must be made in writing and must include: a) A completed authority prescription form; and b) A completed Familial homozygous hypercholesterolaemia Initial PBS 'Grandfather' Authority Application - Supporting Information Form; and c) The date of consultation and the full name of the consultant physician; and d) A copy of the qualifying Dutch Lipid Clinic Network Score or a copy of the result of genetic testing; and e) The result of LDL cholesterol level and one of the following where appropriate: statin treatment details including agent, dose and treatment duration; or details of adverse event or contraindication to treatment with a statin as defined in the TGA-approved Product Information. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, omit entry for Foscarnet
Schedule 4, Part 1, entry for Goserelin
insert in numerical order after existing text:
| C7164 | Anticipated premature ovarian failure Patient must be receiving treatment with an alkylating agent for a malignancy or an autoimmune disorder that has a high risk of causing premature ovarian failure; AND Patient must not receive more than 6 months' of treatment for this condition in a lifetime. Patient must be pre-menopausal. |
Schedule 4, Part 1, entry for Ibandronic acid
(a)omit from the column headed “Circumstances and Purposes” for Circumstances Code C5257:
Where the patient is receiving treatment at/from a private hospital
(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C5291:
Where the patient is receiving treatment at/from a public hospital
Schedule 4, Part 1, after entry for Ibandronic acid
insert:
| Ibrutinib | C7260 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Continuing treatment The treatment must be as monotherapy; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
| C7337 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment The treatment must be as monotherapy; AND The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have a WHO performance status of 0 or 1; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be considered unsuitable for treatment or retreatment with a purine analogue. A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following: a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles; b) Age is 70 years or older; c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen; d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia; e) Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH). | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Icatibant
substitute:
| C7273 | Anticipated emergency treatment of an acute attack of hereditary angioedema Initial Patient must have confirmed diagnosis of C1-esterase inhibitor deficiency; AND Patient must have been assessed to be at significant risk of an acute attack of hereditary angioedema; AND The condition must be assessed by a clinical immunologist; OR The condition must be assessed by a respiratory physician; OR The condition must be assessed by a specialist allergist; OR The condition must be assessed by a general physician experienced in the management of patients with hereditary angioedema. The name of the specialist consulted must be provided at the time of application for initial supply. The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application. Increased maximum quantities will be limited to 12 injections per authority prescription. | Compliance with Authority Required procedures |
| C7274 | Anticipated emergency treatment of an acute attack of hereditary angioedema Continuing Patient must have previously received PBS-subsidised treatment with this drug for this condition. Increased maximum quantities will be limited to 12 injections per authority prescription. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Idelalisib
(a)omit:
| C7051 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C7310 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with rituximab; AND The condition must have relapsed or be refractory to at least one prior therapy; AND The condition must be CD20 positive; AND Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); AND Patient must be inappropriate for chemo-immunotherapy. A patient can be considered inappropriate for chemo-immunotherapy when one or more of the following are experienced: 1. Severe neutropenia defined as absolute neutrophil count of less than or equal to 1.0 x 109/L; or 2. Severe thrombocytopenia defined as platelet count of less than or equal to 50 x 109/L; or 3. Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH). Full blood count results must be no more than 1 month old at the time of application. The authority application must be made in writing and must include: a) A completed authority prescription form; b) A completed CLL/SLL PBS Authority Application - Supporting information form; and c) Pathology report indicating that the patient can be considered inappropriate for chemo-immunotherapy due to one or more of the following: 1) Recent severe neutropenia; or 2) Recent severe thrombocytopenia; or 3) Presence of 17p chromosomal deletion using fluorescence in situ hybridisation (FISH). | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Milk powder—lactose free formula
(a)omit from the column headed “Purposes Code” for Circumstances Code C4324: P4324
(b)omit:
| 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 |
(c)insert in numerical order after existing text:
| C7198 | Acute lactose intolerance Patient must be up to the age of 12 months. The date of birth of the patient must be provided at the time of application. | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Milk powder—lactose free formula
insert:
| Milk powder lactose intolerance formula | C7257 | Acute lactose intolerance Patient must be up to the age of 12 months. The date of birth of the patient must be provided at the time of application. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Pemetrexed
(a)omit:
| C4789 | Mesothelioma The treatment must be in combination with cisplatin Doses greater than 500 mg per metre squared BSA are not PBS-subsidised | Compliance with Authority Required procedures - Streamlined Authority Code 4789 |
(b)insert in numerical order after existing text:
| C7195 | Mesothelioma The treatment must be in combination with platinum-based chemotherapy. The patient's body surface area (BSA) must be documented in the patient's medical records at the time the treatment cycle is initiated Doses greater than 500 mg per metre squared BSA are not PBS-subsidised | Compliance with Authority Required procedures - Streamlined Authority Code 7195 |
Schedule 4, Part 1, entry for Secukinumab
(a)omit:
| C6437 | P6437 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND (3) a signed patient acknowledgement. | Compliance with Written Authority Required procedures |
(b)omit:
| C6467 | P6467 | Severe psoriatic arthritis initial treatment - Initial 2 (change or recommencing treatment after a break of less than 5 years ) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab or ustekinumab. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form. Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug. Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased. Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). | Compliance with Written Authority Required procedures |
(c)omit:
| C6483 | P6483 | Severe active psoriatic arthritis Initial 3 (grandfather treatment) or Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Initial 3 (grandfather patients) restriction to complete maximum of 24 weeks treatment; AND Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
(d)omit:
| C6485 | P6485 | Severe active psoriatic arthritis Initial 3 - grandfather treatment Patient must have a documented history of severe active psoriatic arthritis; AND (5) results of the baseline patient assessment prior to commencing treatment with this drug. | Compliance with Written Authority Required procedures |
| C6486 | P6486 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND | Compliance with Written Authority Required procedures |
| C6487 | P6487 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencing treatment after a break of less than 5 years) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete maximum of 16 weeks of treatment; OR | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Vismodegib
insert:
| Vitamins, minerals and trace elements formula | C7275 | Dietary management of conditions requiring a highly restrictive therapeutic diet Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND |
Schedule 5, after entry for Esomeprazole and Clarithromycin and Amoxycillin
insert:
| Etanercept | GRP-21357 | Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Injection | Brenzys Enbrel |
| GRP-21359 | Injection 50 mg in 1 mL single use auto-injector, 4 | Injection | Brenzys Enbrel |
Schedule 5, entry for Hydroxocobalamin in the form Injection 1 mg (as acetate) in 1 mL [GRP-17689]
insert in alphabetical order in the column headed “Brand”: Cobal-B12
Schedule 5, entry for Olanzapine in the form Tablet 2.5 mg [GRP-15492]
insert in alphabetical order in the column headed “Brand”: PRYZEX
Schedule 5, entry for Olanzapine in the form Tablet 5 mg [GRP-15921]
insert in alphabetical order in the column headed “Brand”: PRYZEX
Schedule 5, entry for Olanzapine in the form Tablet 7.5 mg [GRP-15884]
insert in alphabetical order in the column headed “Brand”: PRYZEX
Schedule 5, entry for Olanzapine in the form Tablet 10 mg [GRP-15513]
insert in alphabetical order in the column headed “Brand”: PRYZEX
Schedule 5, after entry for Olanzapine in the form Tablet 10 mg (as benzoate) [GRP-15513]
insert:
| GRP-15797 | Tablet 5 mg (orally disintegrating) | Oral | APO-Olanzapine ODT |
| Wafer 5 mg | Oral | Zypine ODT | |
| GRP-15723 | Tablet 10 mg (orally disintegrating) | Oral | APO-Olanzapine ODT |
| Wafer 10 mg | Oral | Zypine ODT |
Schedule 5, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21535]
insert in alphabetical order in the column headed “Brand”: Salbutamol AN
Schedule 5, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21361]
insert in alphabetical order in the column headed “Brand”: Salbutamol AN
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