National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015) (Cth)
PB 117 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 12)
National Health Act 1953
I, PENNY SHAKESPEARE, 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 21 December 2015
PENNY SHAKESPEARE
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 2015 (No. 12).
(2) This Instrument may also be cited as PB 117 of 2015.
2 Commencement
This Instrument commences on 1 January 2016.
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, entry for Alendronic Acid
omit:
| Ossmax 70mg | RA | MP NP | C4882 C4885 C4889 | 4 | 5 | 4 |
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
(a)omit:
| APO-Alendronate Plus D3 70 mg/70 mcg | TX | MP NP | C4070 C4087 C4110 | 4 | 5 | 4 |
(b)omit:
| Chem mart Alendronate Plus D3 70 mg/70 mcg | CH | MP NP | C4070 C4087 C4110 | 4 | 5 | 4 |
(c)omit:
| Terry White Chemists Alendronate Plus D3 70 mg/70 mcg | TW | MP NP | C4070 C4087 C4110 | 4 | 5 | 4 |
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
(a)omit:
| APO-Alendronate Plus D3 70 mg/140 mcg | TX | MP NP | C4122 C4123 C4133 | 4 | 5 | 4 |
(b)omit:
| Chem mart Alendronate Plus D3 70 mg/140 mcg | CH | MP NP | C4122 C4123 C4133 | 4 | 5 | 4 |
(c)omit:
| Terry White Chemists Alendronate Plus D3 70 mg/140 mcg | TW | MP NP | C4122 C4123 C4133 | 4 | 5 | 4 |
Schedule 1, entry for Alginic acid with calcium carbonate and sodium bicarbonate
insert in the column headed “Circumstances”: C5837
Schedule 1, entry for Aluminium Hydroxide with Magnesium Hydroxide
insert in the column headed “Circumstances”: C5837
Schedule 1, omit entry for Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
Schedule 1, entry for Amoxycillin in the form Tablet 1 g (as trihydrate)
omit from the column headed “Circumstances” (twice occurring): C1582 substitute: C5843
Schedule 1, entry for Amoxycillin in the form Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL [Maximum Quantity: 1; Number of Repeats: 1]
(a)omit from the column headed “Brand”: Amoxil
(b)omit from the column headed “Responsible Person”: AS
(c)insert in the column headed “Circumstances”: C5863
Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL
(a)omit:
| GenRx Amoxycillin | GX | PDP | 1 | 0 | 1 |
(b)omit:
| GenRx Amoxycillin | GX | MP NP | 1 | 1 | 1 |
Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL
(a)omit:
| GenRx Amoxycillin | GX | PDP | 1 | 0 | 1 |
(b)omit:
| GenRx Amoxycillin | GX | MP NP | 1 | 1 | 1 |
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]
(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 | AlphaClav Duo | AF | PDP | C5833 C5894 | 10 | 0 | 10 |
(c)omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894
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]
(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 | AlphaClav Duo | AF | MP NP MW | C5832 C5893 | 10 | 1 | 10 |
(c)omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893
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]
(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 | AlphaClav Duo Forte | AF | PDP | C5833 C5894 | 10 | 0 | 10 |
(c)omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894
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]
(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 | AlphaClav Duo Forte | AF | MP NP MW | C5832 C5893 | 10 | 1 | 10 |
(c)omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats: 0]
omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats: 1]
omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the forms: Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats: 0]
omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the forms: Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats: 1]
omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893
Schedule 1, entry for Aspirin in the form Tablet 100 mg
(a)omit:
| Astrix | YN | MP NP | 112 | 1 | 112 |
(b)omit:
| Mayne Pharma Aspirin | YT | MP NP | 112 | 1 | 112 |
(c)insert in the column headed “Circumstances” for the brand “Spren 100”: C5884
Schedule 1, entry for Aspirin in the form Tablet, dispersible, 300 mg
(a)insert in the column headed “Circumstances” [Authorised Prescriber PDP]:C5870
(b)insert in the column headed “Circumstances” [Authorised Prescriber MP NP]:C5857
Schedule 1, omit entry for Atorvastatin and ezetimibe
Schedule 1, entry for Biperidin
omit from the column headed “Responsible Person”: LM substitute: ZC
Schedule 1, entry for Bisacodyl
omit:
| Suppositories 10 mg, 10 | Rectal | a | Dulcolax | BY | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 |
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 | ||
| a | Dulcolax | BY | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | ||
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | ||
| a | Dulcolax | BY | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 5 | 1 | ||
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 5 | 1 | ||
| Dulcolax | BY | MP | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||
| Petrus Bisacodyl Suppositories | PP | MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | ||
| Suppositories 10 mg, 12 | Rectal | Petrus Bisacodyl Suppositories | PP | MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5641 | 3 | 0 | 1 | |
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5774 | 3 | 3 | 1 | |||||
| MP NP | C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 3 | 4 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) |
substitute:
| Suppositories 10 mg, 10 | Rectal | a | Dulcolax | BY | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5641 | 3 | 0 | 1 |
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5641 | 3 | 0 | 1 | ||
| a | Dulcolax | BY | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5774 | 3 | 3 | 1 | ||
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5774 | 3 | 3 | 1 | ||
| a | Dulcolax | BY | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 5 | 1 | ||
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 5 | 1 | ||
| Dulcolax | BY | MP | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||
| Petrus Bisacodyl Suppositories | PP | MP | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||
| Suppositories 10 mg, 12 | Rectal | Petrus Bisacodyl Suppositories | PP | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5641 | 3 | 0 | 1 | |
| MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5774 | 3 | 3 | 1 | |||||
| MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 4 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) |
Schedule 1, entry for Buprenorphine in each of the forms: Tablet (sublingual) 400 micrograms (as hydrochloride); Tablet (sublingual) 2 mg (as hydrochloride); and Tablet (sublingual) 8 mg (as hydrochloride)
omit from the column headed “Responsible Person”: RC substitute: IR
Schedule 1, entry for Buprenorphine with naloxone in each of the forms: Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride); and Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)
omit from the column headed “Responsible Person”: RC substitute: IR
Schedule 1, entry for Calcitriol
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Calcitriol | TX | MP NP | C5089 C5114 C5255 C5401 C5402 | 100 | 3 | 100 |
(b)insert in the column headed “Schedule Equivalent” for all brands: a
Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
(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 | Asartan HCT 16/12.5 | DO | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
(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 | Asartan HCT 32/12.5 | DO | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
(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 | Asartan HCT 32/25 | DO | MP NP | C4374 | 30 | 5 | 30 |
Schedule 1, entry for Capecitabine in the form Tablet 150 mg
omit:
| Xeloda | RO | MP | 60 | 2 | 60 |
Schedule 1, entry for Carbimazole
omit from the column headed “Responsible Person”: LM substitute: ZC
Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g (as hydrochloride)
omit from the column headed “Circumstances” (all instances): C1427 substitute: C5842
Schedule 1, entry for Cefotaxime in the form Powder for injection 1 g (as sodium)
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP NP] (twice occurring):C1169 C1846 C1847
substitute: C5827 C5828 C5829(b)omit from the column headed “Circumstances” [Authorised Prescriber PDP] (twice occurring):C1169 substitute: C5892
Schedule 1, entry for Cefotaxime in the form Powder for injection 2 g (as sodium)
(a)omit:
| Cefotaxime Sandoz | SZ | MP NP | C1169 C1846 C1847 | 10 | 0 | 1 |
| PDP | C1169 | 10 | 0 | 1 |
(b)omit from the column headed “Circumstances” for the brand “Hospira Pty Limited” [Authorised Prescriber MP NP]: C1169 C1846 C1847
substitute: C5826 C5881 C5890(c)omit from the column headed “Circumstances” for the brand “Hospira Pty Limited” [Authorised Prescriber PDP]: C1169 substitute: C5519
Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium) [Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C1143 C1169 C1846 C1847 substitute: C5826 C5855 C5881 C5890
(b)omit from the column headed “Purposes”: P1143 substitute: P5855
Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium) [Maximum Quantity: 5; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C1143 C1169 C1846 C1847 substitute: C5826 C5855 C5881 C5890
(b)omit from the column headed “Purposes”: P1169 P1846 P1847 substitute: P5826 P5881 P5890
Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)
omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 substitute: C5830 C5862 C5868
Schedule 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)
omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 substitute: C5826 C5881 C5890
Schedule 1, entry for Cephazolin in the form Powder for injection 500 mg (as sodium)
omit from the column headed “Circumstances”: C1169 C1846 C1847 C3132 substitute: C5826 C5867 C5881 C5890
Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)
omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 C3132 substitute: C5861 C5882 C5883 C5891
Schedule 1, entry for Cephazolin in the form Powder for injection 2 g (as sodium)
(a)omit:
| Cefazolin Sandoz | SZ | MP NP | C1169 C1846 C1847 C3132 | 10 | 0 | 1 |
(b)omit from the column headed “Circumstances” for the brand “Cephazolin Alphapharm”: C1169 C1846 C1847 C3132
substitute: C5826 C5867 C5881 C5890
Schedule 1, omit entry for Chloramphenicol
Schedule 1, entry for Chlorthalidone
omit from the column headed “Responsible Person”: LM substitute: ZC
Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit:
| Klacid | GO | MP | P1434 P3325 | 100 CN1434 CN3325 | 2 CN1434 CN3325 | 100 | C(100) |
Schedule 1, entry for Clarithromycin in the form Tablet 500 mg
(a)omit from the column headed “Brand”: Klacid substitute: APO-Clarithromycin
(b)omit from the column headed “Responsible Person”: GO substitute: TX
(c)omit from the column headed “Circumstances”: C1434 C3325 substitute: C5873 C5874
Schedule 1, entry for Cyproheptadine
omit from the column headed “Circumstances”: C1288 substitute: C5858
Schedule 1, entry for Electrolyte Replacement, Oral
(a)omit:
| O.R.S. | AS | MP NP | 1 | 0 | 1 |
(b)insert in the column headed “Circumstances” for the brands “Repalyte New Formulation” and “restore O.R.S.”: C5889
Schedule 1, entry for Erythromycin in the form Tablet 400 mg (as ethyl succinate)
omit from the column headed “Responsible Person” for the brand “E.E.S. 400 Filmtab” (twice occurring): LM substitute: ZC
Schedule 1, entry for Erythromycin in the form Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL
omit from the column headed “Responsible Person” for the brand “E.E.S. 200” (twice occurring): LM substitute: ZC
Schedule 1, entry for Erythromycin in the form Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL
omit from the column headed “Responsible Person” for the brand “E.E.S. Granules” (twice occurring): LM substitute: ZC
Schedule 1, entry for Erythromycin in the form Powder for I.V. infusion 1 g (as lactobionate)
omit from the column headed “Responsible Person”: LM substitute: ZC
Schedule 1, entry for Famciclovir in the form Tablet 125 mg
(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 | Auro-Famciclovir 125 | DO | MP NP | C3624 | 40 | 1 | 40 |
Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 30; Number of Repeats: 0]
(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 | Auro-Famciclovir 500 | DO | MP NP | C3625 C3626 C3627 C3628 C3629 | P3625 | 30 | 0 | 30 |
Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in numerical order in the column headed “Circumstances” for the brand “Auro-Famciclovir 500”: C3625
(c)insert in the column headed “Purposes” for the brand “Auro-Famciclovir 500”: P3626 P3627 P3628 P3629
Schedule 1, omit entry for Ferrous fumarate
Schedule 1, omit entry for Ferrous Fumarate with Folic Acid
Schedule 1, entry for Folic Acid in the form Tablet 500 micrograms
insert in the column headed “Circumstances” for the brands “Foltabs 500” and “Megafol 0.5”: C5824
Schedule 1, entry for Folic Acid Tablet 5 mg
insert in the column headed “Circumstances”: C5820
Schedule 1, entry for Glucose and Ketone Indicator—Urine
substitute:
| Glucose and Ketone Indicator—Urine | Test strips, 50 (Keto‑Diabur‑Test 5000) | For external use | Keto‑Diabur‑Test 5000 | RD | MP NP | C5852 | 2 | 2 | 1 |
| Test strips, 50 (Keto‑Diastix) | For external use | Keto‑Diastix | BN | MP NP | C5852 | 2 | 2 | 1 |
Schedule 1, entry for Glucose Indicator—Blood
(a)omit:
| Test strips, 51 (Accu‑Chek Integra) | For external use | Accu‑Chek Integra | RD | MP NP | 2 | 5 | 1 |
| MP | P4241 | 2 | 11 | 1 |
(b)omit:
| Test strips, 100 (GoodLife) | For external use | GoodLife | JN | MP NP | 1 | 5 | 1 |
| MP | P4241 | 1 | 11 | 1 |
Schedule 1, entry for Glucose Indicator—Urine
substitute:
| Glucose Indicator—Urine | Test strips, 50 (Diastix) | For external use | Diastix | BN | MP NP | C5852 | 2 | 2 | 1 |
Schedule 1, entry for Glycerol
substitute:
| Glycerol | Suppositories 700 mg, 12 | Rectal | Petrus Pharmaceuticals Pty Ltd | PP | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5641 | 3 | 0 | 1 |
| MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5774 | 3 | 3 | 1 | |||||
| MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 5 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||||
| Suppositories 1.4 g, 12 | Rectal | Petrus Pharmaceuticals Pty Ltd | PP | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5641 | 3 | 0 | 1 | |
| MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5774 | 3 | 3 | 1 | |||||
| MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 5 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||||
| Suppositories 2.8 g, 12 | Rectal | Petrus Pharmaceuticals Pty Ltd | PP | MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5641 | 3 | 0 | 1 | |
| MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5774 | 3 | 3 | 1 | |||||
| MP NP | C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 5 | 1 | |||||
| MP | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) |
Schedule 1, entry for Hydrocortisone
(a)omit:
| Cream containing hydrocortisone acetate 10 mg per g, 30 g | Application | Cortic‑DS 1% | FM | PDP | C4899 C4934 | P4934 | 1 | 0 | 1 |
| Sigmacort | QA | PDP | C4899 C4934 | P4934 | 1 | 0 | 1 | ||
| Cortic‑DS 1% | FM | MP NP | C4899 C4934 | P4899 | 1 | 1 | 1 | ||
| Sigmacort | QA | MP NP | C4899 C4934 | P4899 | 1 | 1 | 1 |
(b)omit:
| Ointment containing hydrocortisone acetate 10 mg per g, 30 g | Application | Cortic‑DS 1% | FM | PDP | C4899 C4934 | P4934 | 1 | 0 | 1 |
| Sigmacort | QA | PDP | C4899 C4934 | P4934 | 1 | 0 | 1 | ||
| Cortic‑DS 1% | FM | MP NP | C4899 C4934 | P4899 | 1 | 1 | 1 | ||
| Sigmacort | QA | MP NP | C4899 C4934 | P4899 | 1 | 1 | 1 |
Schedule 1, entry for Hydroxocobalamin in the form Injection 1 mg (as acetate) in 1 mL
omit from the column headed “Circumstances”: C4111 C4134 C4135 substitute: C5840 C5841 C5854
Schedule 1, entry for Hydroxocobalamin in the form Injection 1 mg (as chloride) in 1 mL
(a)omit:
| Hydroxo‑B12 | AS | MP NP | C4111 C4134 C4135 | 3 | 0 | 3 |
(b)omit from the column headed “Circumstances” for the brand “Neo‑B12”: C4111 C4134 C4135 substitute: C5840 C5841 C5854
Schedule 1, entry for Imipramine in the form Tablet containing imipramine hydrochloride 10 mg
omit from the column headed “Responsible Person” for the brand “Tofranil 10”: LM substitute: ZC
Schedule 1, entry for Imipramine in the form Tablet containing imipramine hydrochloride 25 mg
omit from the column headed “Responsible Person” for the brand “Tofranil 25”: LM substitute: ZC
Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
omit:
| Hospira Pty Limited | HH | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
insert in the column headed “Schedule Equivalent” for all brands: a
Schedule 1, entry for Naratriptan
(a)omit from the column headed “Circumstances”: C3281 C3282 C3283 C3284 C3285
(b)insert in numerical order after existing “Circumstances” code: C5849 C5850 C5859 C5860 C5887
Schedule 1, entry for Nystatin
omit:
| Oral suspension 100,000 units per mL, 24 mL | Oral | Mycostatin | FM | PDP | 1 | 0 | 1 |
| Nilstat | QA | PDP | 1 | 0 | 1 | ||
| Mycostatin | FM | MP NP | 1 | 1 | 1 | ||
| Nilstat | QA | MP NP | 1 | 1 | 1 |
Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; Tablet 10 mg; Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg (as benzoate); Tablet 10 mg (as benzoate); Tablet 5 mg (orally disintegrating); Tablet 10 mg (orally disintegrating); Tablet 15 mg (orally disintegrating); Tablet 20 mg (orally disintegrating); Wafer 5 mg; Wafer 10 mg; Wafer 15 mg; and Wafer 20 mg
omit from the column headed “Circumstances” (all instances): C1589 C2044 substitute: C5856 C5869
Schedule 1, entry for Paracetamol
substitute:
| Paracetamol | Suppositories 500 mg, 24 | Rectal | Panadol | GC | MP NP | C4940 C4950 | P4950 | 4 | 0 | 1 |
| MP NP | C4940 C4950 | P4940 | 4 | 3 | 1 | |||||
| Oral liquid 120 mg per 5 mL, 100 mL | Oral | Panamax | SW | PDP | C5846 | 1 | 0 | 1 | ||
| MP NP | C5835 | 1 | 2 | 1 | ||||||
| Oral liquid 240 mg per 5 mL, 200 mL | Oral | Panamax 240 Elixir | SW | PDP | C5846 | 1 | 0 | 1 | ||
| MP NP | C5835 | 1 | 2 | 1 | ||||||
| Tablet 500 mg | Oral | a | APO-Paracetamol | TX | PDP | C5846 C5885 | P5846 | 100 | 0 | 100 |
| a | Febridol | EA | PDP | C5846 C5885 | P5846 | 100 | 0 | 100 | ||
| a | Generic Health Pty Ltd | GQ | PDP | C5846 C5885 | P5846 | 100 | 0 | 100 | ||
| a | Panamax | SW | PDP | C5846 C5885 | P5846 | 100 | 0 | 100 | ||
| a | Paracetamol (Sandoz) | SZ | PDP | C5846 C5885 | P5846 | 100 | 0 | 100 | ||
| a | Paralgin | FM | PDP | C5846 C5885 | P5846 | 100 | 0 | 100 | ||
| a | Parapane | AF | PDP | C5846 C5885 | P5846 | 100 | 0 | 100 | ||
| a | APO-Paracetamol | TX | MP NP | C5835 C5865 | P5835 | 100 | 1 | 100 | ||
| a | Febridol | EA | MP NP | C5835 C5865 | P5835 | 100 | 1 | 100 | ||
| a | Generic Health Pty Ltd | GQ | MP NP | C5835 C5865 | P5835 | 100 | 1 | 100 | ||
| a | Panamax | SW | MP NP | C5835 C5865 | P5835 | 100 | 1 | 100 | ||
| a | Paracetamol (Sandoz) | SZ | MP NP | C5835 C5865 | P5835 | 100 | 1 | 100 | ||
| a | Paralgin | FM | MP NP | C5835 C5865 | P5835 | 100 | 1 | 100 | ||
| a | Parapane | AF | MP NP | C5835 C5865 | P5835 | 100 | 1 | 100 | ||
| a | APO-Paracetamol | TX | PDP | C5846 C5885 | P5885 | 300 | 0 | 100 | ||
| a | Febridol | EA | PDP | C5846 C5885 | P5885 | 300 | 0 | 100 | ||
| a | Generic Health Pty Ltd | GQ | PDP | C5846 C5885 | P5885 | 300 | 0 | 100 | ||
| a | Panamax | SW | PDP | C5846 C5885 | P5885 | 300 | 0 | 100 | ||
| a | Paracetamol (Sandoz) | SZ | PDP | C5846 C5885 | P5885 | 300 | 0 | 100 | ||
| a | Paralgin | FM | PDP | C5846 C5885 | P5885 | 300 | 0 | 100 | ||
| a | Parapane | AF | PDP | C5846 C5885 | P5885 | 300 | 0 | 100 | ||
| a | APO-Paracetamol | TX | MP NP | C5835 C5865 | P5865 | 300 | 4 | 100 | ||
| a | Febridol | EA | MP NP | C5835 C5865 | P5865 | 300 | 4 | 100 | ||
| a | Generic Health Pty Ltd | GQ | MP NP | C5835 C5865 | P5865 | 300 | 4 | 100 | ||
| a | Panamax | SW | MP NP | C5835 C5865 | P5865 | 300 | 4 | 100 | ||
| a | Paracetamol (Sandoz) | SZ | MP NP | C5835 C5865 | P5865 | 300 | 4 | 100 | ||
| a | Paralgin | FM | MP NP | C5835 C5865 | P5865 | 300 | 4 | 100 | ||
| a | Parapane | AF | MP NP | C5835 C5865 | P5865 | 300 | 4 | 100 | ||
| Tablet 665 mg (modified release) | Oral | Osteomol 665 Paracetamol | CR | MP NP | C4940 C4950 C5847 | P4950 | 192 | 0 | 96 | |
| MP NP | C4940 C4950 C5847 | P4940 | 192 | 3 | 96 | |||||
| MP NP | C4940 C4950 C5847 | P5847 | 192 | 5 | 96 |
Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium heptahydrate)
(a)insert in the column headed “Schedule Equivalent” for the brand “Alimta”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pemetrexed MYX | YN | MP | C4789 C4792 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium heptahydrate)
(a)insert in the column headed “Schedule Equivalent” for the brand “Alimta”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pemetrexed MYX | YN | MP | C4789 C4792 | See Note 3 | See Note 3 | 1 | D(100) |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Pemetrexed Sandoz | SZ | MP | C4789 C4792 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Propranolol in each of the forms: Tablet containing propranolol hydrochloride 10 mg; and Tablet containing propranolol hydrochloride 40 mg
insert in the column headed “Schedule Equivalent” for all brands: a
Schedule 1, entry for Rituximab
omit:
| Solution for I.V. infusion 100 mg in 10 mL | Injection | Mabthera | RO | MP | C4674 C4677 C4678 C4686 C4701 C4706 C4726 | See Note 3 | See Note 3 | See Note 3 | 2 | D(100) |
substitute:
| Solution for I.V. infusion 100 mg in 10 mL | Injection | Mabthera | RO | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
| MP | C4674 C4677 C4678 C4686 C4701 C4706 C4726 | See Note 3 | See Note 3 | See Note 3 | 2 | D(100) |
Schedule 1, entry for Sapropterin
omit from the column headed “Responsible Person”: SG substitute: IO
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg
(a)omit:
| TACROLIMUS APOTEX | TX | MP | 100 | 3 | 100 |
(b)omit:
| TACROLIMUS APOTEX | TX | MP | P5569 P5602 | 200 CN5569 CN5602 | 5 CN5569 CN5602 | 100 | C(100) |
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg
(a)omit:
| TACROLIMUS APOTEX | TX | MP | 100 | 3 | 100 |
(b)omit:
| TACROLIMUS APOTEX | TX | MP | P5569 P5602 | 200 CN5569 CN5602 | 5 CN5569 CN5602 | 100 | C(100) |
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg
(a)omit:
| TACROLIMUS APOTEX | TX | MP | 50 | 3 | 50 |
(b)omit:
| TACROLIMUS APOTEX | TX | MP | P5569 P5602 | 100 CN5569 CN5602 | 5 CN5569 CN5602 | 50 | C(100) |
Schedule 1, entry for Ticarcillin with Clavulanic Acid
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP NP]:C1169 C1846 C1847 substitute: C5826 C5881 C5890
(b)omit from the column headed “Circumstances” [Authorised Prescriber PDP]:C1169 substitute: C5831
Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 0](a)omit from the column headed “Circumstances” [Authorised Prescriber MP NP] (all instances):C1497 C1615 substitute: C5848 C5877
(b)omit from the column headed “Purposes” (all instances): P1497 substitute: P5877
(c)omit from the column headed “Circumstances” [Authorised Prescriber PDP] (all instances):C1497 C1615 substitute: C5875 C5876
Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 2](a)omit from the column headed “Circumstances” (all instances): C1497 C1615 substitute: C5848 C5877
(b)omit from the column headed “Purposes” (all instances): P1615 substitute: P5848
Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 50 mg; Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg
omit from the column headed “Circumstances” (all instances): C1537 substitute: C5822
Schedule 1, entry for Tramadol
omit:
| Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL | Oral | Tramal | CS | MP NP PDP | C1537 | 1 | 0 | 1 |
| Injection containing tramadol hydrochloride 100 mg in 2 mL | Injection | Tramadol ACT | EA | MP NP PDP | C1378 | 5 | 0 | 5 |
| Tramadol Sandoz | SZ | MP NP PDP | C1378 | 5 | 0 | 5 | ||
| Tramal 100 | CS | MP NP PDP | C1378 | 5 | 0 | 5 |
substitute:
| Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL | Oral | Tramal | CS | MP NP | C5822 | 1 | 0 | 1 |
| PDP | C5878 | 1 | 0 | 1 | ||||
| Injection containing tramadol hydrochloride 100 mg in 2 mL | Injection | Tramadol ACT | EA | MP NP | C5886 | 5 | 0 | 5 |
| PDP | C5818 | 5 | 0 | 5 | ||||
| Tramadol Sandoz | SZ | MP NP | C5886 | 5 | 0 | 5 | ||
| PDP | C5818 | 5 | 0 | 5 | ||||
| Tramal 100 | CS | MP NP | C5886 | 5 | 0 | 5 | ||
| PDP | C5818 | 5 | 0 | 5 |
Schedule 1, entry for Trandolapril in each of the forms: Capsule 500 micrograms; Capsule 1 mg; Capsule 2 mg; and Capsule 4 mg
omit:
| APO‑Trandolapril | TX | MP NP | 28 | 5 | 28 |
Schedule 1, entry for Trastuzumab in each of the forms: Powder for I.V. infusion 60 mg; and Powder for I.V. infusion 150 mg
insert in numerical order in the column headed “Circumstances”: C5825 C5834 C5844
Schedule 1, entry for Triglycerides, medium chain in each of the forms: Oil 500 mL (MCT Oil); and Oral emulsion 250 mL (Liquigen)
(a)omit from the column headed “Circumstances”: C5616
(b)insert in numerical order: C5853 C5888
Schedule 3, Responsible Person code GH
omit from the column headed “Responsible Person”: Mercury Pharma (Australia) Pty Limited
substitute: Amdipharm Mercury (Australia) Pty LimitedSchedule 3, after details relevant to Responsible Person code IK
insert:
| IO | BioMarin Pharmaceutical Australia Pty Ltd | 69 159 743 496 |
Schedule 3, after details relevant to Responsible Person code IQ
insert:
| IR | Indivior Pty Ltd | 22 169 280 102 |
Schedule 3
omit:
| JN | JNS Biomedical Pty Ltd | 79 163 593 833 |
Schedule 3, after details relevant to Responsible Person code YT
insert:
| ZC | Anspec Pty Limited | 13 056 263 239 |
Schedule 4, Part 1, after entry for Alendronic acid with colecalciferol and calcium
insert:
| Alginic acid with calcium carbonate and sodium bicarbonate | C5837 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
Schedule 4, Part 1, after entry for Alprazolam
insert:
| Aluminium hydroxide with magnesium hydroxide | C5837 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
Schedule 4, Part 1, entry for Amoxycillin
substitute:
| Amoxycillin | C5843 | Chronic bronchitis Patient must have acute exacerbations of the condition. |
| C5863 | Infection suspected or proven to be due to a susceptible organism The treatment must be for patients who require a liquid formulation and in whom the syrup formulations are unsuitable. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Amoxycillin with Clavulanic Acid
substitute:
| Amoxycillin with clavulanic acid | C5832 | Infections where resistance to amoxycillin is proven |
| C5833 | Infection where resistance to amoxycillin is suspected | |
| C5893 | Infection where resistance to amoxycillin is suspected | |
| C5894 | Infections where resistance to amoxycillin is proven |
Schedule 4, Part 1, after entry for Asenapine
insert:
| Aspirin | C5857 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
| C5870 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
| C5884 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
Schedule 4, Part 1, omit entry for Atorvastatin and ezetimibe
Schedule 4, Part 1, entry for Bisacodyl
insert in numerical order:
| C5819 | P5819 | Constipation Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. Patient must identify as Aboriginal or Torres Strait Islander. |
| C5823 | P5823 | Anorectal congenital abnormalities Patient must identify as Aboriginal or Torres Strait Islander. |
| C5851 | P5851 | Terminal malignant neoplasia Patient must identify as Aboriginal or Torres Strait Islander. |
| C5866 | P5866 | Megacolon Patient must identify as Aboriginal or Torres Strait Islander. |
| C5879 | P5879 | Constipation Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. Patient must identify as Aboriginal or Torres Strait Islander. |
Schedule 4, Part 1, entry for Buprenorphine [Circumstances Code C4951]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, entry for Cefepime
substitute:
| Cefepime | C5842 | Febrile neutropenia | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Cefotaxime
substitute:
| Cefotaxime | C5519 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
| C5826 | Septicaemia, suspected | |
| C5827 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C5828 | Septicaemia, suspected | |
| C5829 | Septicaemia, proven | |
| C5881 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C5890 | Septicaemia, proven | |
| C5892 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Schedule 4, Part 1, entry for Ceftriaxone
substitute:
| Ceftriaxone | C5826 | P5826 | Septicaemia, suspected |
| C5830 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | ||
| C5855 | P5855 | Gonorrhoea | |
| C5862 | Septicaemia, proven | ||
| C5868 | Septicaemia, suspected | ||
| C5881 | P5881 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C5890 | P5890 | Septicaemia, proven |
Schedule 4, Part 1, entry for Cephazolin
substitute:
| Cephazolin | C5826 | Septicaemia, suspected |
| C5861 | Septicaemia, suspected | |
| C5867 | Cellulitis | |
| C5881 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C5882 | Septicaemia, proven | |
| C5883 | Cellulitis | |
| C5890 | Septicaemia, proven | |
| C5891 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Schedule 4, Part 1, entry for Clarithromycin
(a)omit:
| C1434 | Where the patient is receiving treatment at/from a private hospital Treatment of Mycobacterium avium complex infections | Compliance with Written or Telephone Authority Required procedures |
(b)omit:
| C3325 | Where the patient is receiving treatment at/from a public hospital Treatment of Mycobacterium avium complex infections | Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3325 |
(c)insert in numerical order after existing text
| C5873 | Where the patient is receiving treatment at/from a private hospital Mycobacterium avium complex infection | Compliance with Written or Telephone Authority Required procedures |
| C5874 | Where the patient is receiving treatment at/from a public hospital Mycobacterium avium complex infection | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5874 |
Schedule 4, Part 1, entry for Codeine with paracetamol [Purposes Code P4903]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, entry for Cyproheptadine
substitute:
| Cyproheptadine | C5858 | Prevention of migraine |
Schedule 4, Part 1, after entry for Eformoterol
insert:
| Electrolyte replacement, oral | C5889 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
Schedule 4, Part 1, entry for Fentanyl [Circumstances Code C4952]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, after entry for Fluvoxamine
insert:
| Folic acid | C5820 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
| C5824 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
Schedule 4, Part 1, entry for Glucose and Ketone Indicator—Urine
substitute:
| Glucose and ketone indicator—urine | C5852 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
Schedule 4, Part 1, entry for Glucose Indicator—Urine
substitute:
| Glucose indicator—urine | C5852 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
Schedule 4, Part 1, entry for Glycerol
(a)omit:
| C5613 | P5613 | Constipation Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. |
(b)omit:
| C5685 | P5685 | Anorectal congenital abnormalities |
| C5720 | P5720 | Constipation Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. |
(c)omit:
| C5776 | P5776 | Terminal malignant neoplasia |
| C5804 | P5804 | Megacolon |
(d)insert in numerical order after existing text:
| C5819 | P5819 | Constipation Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. Patient must identify as Aboriginal or Torres Strait Islander. |
| C5823 | P5823 | Anorectal congenital abnormalities Patient must identify as Aboriginal or Torres Strait Islander. |
| C5851 | P5851 | Terminal malignant neoplasia Patient must identify as Aboriginal or Torres Strait Islander. |
| C5866 | P5866 | Megacolon Patient must identify as Aboriginal or Torres Strait Islander. |
| C5879 | P5879 | Constipation Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. |
Schedule 4, Part 1, entry for Hydromorphone [Circumstances Codes: C4556; C4926; and C4959]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, entry for Hydroxocobalamin
substitute:
| Hydroxocobalamin | C5840 | Pernicious anaemia Patient must identify as Aboriginal or Torres Strait Islander. |
| C5841 | Anaemias associated with vitamin B12 deficiency Patient must have had a gastrectomy; AND The treatment must be for prophylaxis. Patient must identify as Aboriginal or Torres Strait Islander. | |
| C5854 | Proven vitamin B12 deficiencies other than pernicious anaemia Patient must identify as Aboriginal or Torres Strait Islander. |
Schedule 4, Part 1, entry for Methadone [Circumstances Codes: C4902; C4941; and C4953]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, entry for Morphine [Circumstances Codes: C4556; C4900; C4911; C4926; C4927; C4935; C4948; C4959; and C4960]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, entry for Naratriptan
(a)omit:
| C3281 | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where adverse events have occurred with other suitable PBS‑listed drugs | Compliance with Authority Required procedures |
| C3282 | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions have occurred with other suitable PBS‑listed drugs | Compliance with Authority Required procedures |
| C3283 | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions are expected to occur with other suitable PBS‑listed drugs | Compliance with Authority Required procedures |
| C3284 | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS‑listed drug would cause patient confusion resulting in problems with compliance | Compliance with Authority Required procedures |
| C3285 | Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS‑listed drug is likely to result in adverse clinical consequences | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C5849 | Migraine attack The condition must have usually failed to respond to analgesics in the past; AND | Compliance with Authority Required procedures |
| C5850 | Migraine attack The condition must have usually failed to respond to analgesics in the past; AND | Compliance with Authority Required procedures |
| C5859 | Migraine attack The condition must have usually failed to respond to analgesics in the past; AND | Compliance with Authority Required procedures |
| C5860 | Migraine attack The condition must have usually failed to respond to analgesics in the past; AND | Compliance with Authority Required procedures |
| C5887 | Migraine attack The condition must have usually failed to respond to analgesics in the past; AND | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Olanzapine
(a)omit:
| C1589 | Schizophrenia | Compliance with Authority Required procedures – Streamlined Authority Code 1589 |
| C2044 | Maintenance treatment of bipolar I disorder | Compliance with Authority Required procedures – Streamlined Authority Code 2044 |
(b)insert in numerical order after existing text:
| C5856 | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 5856 |
| C5869 | Bipolar I disorder The treatment must be maintenance therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 5869 |
Schedule 4, Part 1, entry for Oxycodone [Circumstances Codes: C4583; C4926; and C4959]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, entry for Oxycodone with naloxone [Circumstances Code C4951]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, entry for Paracetamol
(a)omit:
| P4913 | Chronic arthropathies |
(b)omit:
| C4969 | P4969 | Persistent pain The condition must be associated with osteoarthritis |
(c)insert in numerical order after existing text:
| C5835 | P5835 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
| C5846 | P5846 | For treatment of a patient identifying as Aboriginal or Torres Strait Islander |
| C5847 | P5847 | Persistent pain The condition must be associated with osteoarthritis. Patient must identify as Aboriginal or Torres Strait Islander. |
| C5865 | P5865 | Chronic arthropathies Patient must identify as Aboriginal or Torres Strait Islander. |
| C5885 | P5885 | Chronic arthropathies Patient must identify as Aboriginal or Torres Strait Islander. |
Schedule 4, Part 1, entry for Tapentadol [Circumstances Code C4556]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
Schedule 4, Part 1, entry for Ticarcillin with Clavulanic Acid
substitute:
| Ticarcillin with clavulanic acid | C5826 | Septicaemia, suspected |
| C5831 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C5881 | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
| C5890 | Septicaemia, proven |
Schedule 4, Part 1, entry for Tramadol
substitute:
| Tramadol | C5818 | Acute pain The treatment must be for the short-term. |
| C5822 | Pain The condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed. | |
| C5848 | P5848 | Chronic pain Dose titration The condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed. |
| C5875 | Acute pain The condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed. | |
| C5876 | Chronic pain Dose titration The condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed. | |
| C5877 | P5877 | Acute pain The condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed. |
| C5878 | Pain The condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed. | |
| C5886 | Acute pain The treatment must be for the short-term. |
Schedule 4, Part 1, entry for Trastuzumab
insert in numerical order:
| C5825 | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction Initial PBS-subsidised treatment (Grandfather patient) Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity; AND | Compliance with Written Authority Required procedures |
| C5834 | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction Continuing treatment Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must not have progressive disease; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment. | Compliance with Written or Telephone Authority Required procedures |
| C5844 | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND Patient must commence treatment in combination with cisplatin and capecitabine; OR Patient must commence treatment in combination with cisplatin and 5 fluorouracil; AND Patient must not have previously received this drug for this condition; AND Patient must not have received prior chemotherapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated in tumour material by both (i) immunohistochemistry (IHC) 2+ or IHC 3+ AND (ii) in situ hybridisation (ISH) results based on both more than 6 copies of HER2 AND the ratio of HER2: chromosome 17 being more than 2 in the same tumour tissue sample Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Triglycerides, medium chain
(a)omit:
| C5616 | Intractable childhood epilepsy Patient must require a ketogenic diet. | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C5853 | Intractable childhood epilepsy Patient must require a ketogenic diet. | Compliance with Authority Required procedures |
| C5888 | Cerebrospinal fluid glucose transporter defect Patient must require a ketogenic diet. | Compliance with Authority Required procedures |
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