National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015) (Cth)

Case

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

  1. Schedule 1, entry for Alendronic Acid

    omit:

Ossmax 70mg RA MP NP C4882 C4885 C4889 4 5 4
  1. 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
  1. 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
  1. Schedule 1, entry for Alginic acid with calcium carbonate and sodium bicarbonate

    insert in the column headed “Circumstances”:        C5837  

  2. Schedule 1, entry for Aluminium Hydroxide with Magnesium Hydroxide

    insert in the column headed “Circumstances”:        C5837  

  3. Schedule 1, omit entry for Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide

  4. Schedule 1, entry for Amoxycillin in the form Tablet 1 g (as trihydrate)

    omit from the column headed “Circumstances” (twice occurring):      C1582   substitute:         C5843

  5. 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  

  6. 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
  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
  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

  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: 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

  1. 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

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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  

  1. 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

  2. Schedule 1, omit entry for Atorvastatin and ezetimibe

  3. Schedule 1, entry for Biperidin

    omit from the column headed “Responsible Person”:                 LM       substitute:             ZC

  4. 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)
  1. 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

  2. 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

  3. 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

  1. 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
  1. 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
  1. 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
  1. Schedule 1, entry for Capecitabine in the form Tablet 150 mg

    omit:

Xeloda RO MP 60 2 60
  1. Schedule 1, entry for Carbimazole

    omit from the column headed “Responsible Person”:                 LM       substitute:             ZC

  2. 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

  3. 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

  4. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  1. Schedule 1, omit entry for Chloramphenicol

  2. Schedule 1, entry for Chlorthalidone

    omit from the column headed “Responsible Person”:                 LM       substitute:             ZC

  1. 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)
  1. 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

  2. Schedule 1, entry for Cyproheptadine

    omit from the column headed “Circumstances”:       C1288   substitute:         C5858

  3. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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
  1. 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
  1. 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

  2. Schedule 1, omit entry for Ferrous fumarate

  3. Schedule 1, omit entry for Ferrous Fumarate with Folic Acid

  4. 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  

  5. Schedule 1, entry for Folic Acid Tablet 5 mg

    insert in the column headed “Circumstances”:        C5820  

  6. 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
  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
  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
  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)
  1. 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
  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

  2. 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

  1. 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

  2. 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

  1. 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)
  1. 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

  2. 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 

  3. 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
  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

  2. 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
  1. 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)
  1. 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)
  1. 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

  2. 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)
  1. Schedule 1, entry for Sapropterin

    omit from the column headed “Responsible Person”:                 SG       substitute:             IO

  2. 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)
  1. 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)
  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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
  1. 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
  1. 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

  2. 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

  3. Schedule 3, Responsible Person code GH

    omit from the column headed “Responsible Person”:                 Mercury Pharma (Australia) Pty Limited          
    substitute:          Amdipharm Mercury (Australia) Pty Limited

  4. Schedule 3, after details relevant to Responsible Person code IK

    insert:

IO BioMarin Pharmaceutical Australia Pty Ltd  69 159 743 496
  1. Schedule 3, after details relevant to Responsible Person code IQ

    insert:

IR Indivior Pty Ltd  22 169 280 102
  1. Schedule 3

    omit:

JN JNS Biomedical Pty Ltd  79 163 593 833
  1. Schedule 3, after details relevant to Responsible Person code YT

    insert:

ZC Anspec Pty Limited  13 056 263 239
  1. 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
  1. 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
  1. 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
  1. 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

  1. 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

  1. Schedule 4, Part 1, omit entry for Atorvastatin and ezetimibe

  2. 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.
  1. 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

  2. Schedule 4, Part 1, entry for Cefepime

    substitute:

Cefepime C5842 Febrile neutropenia Compliance with Authority Required procedures
  1. 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
  1. 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
  1. 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
  1. 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
  1. 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

  2. Schedule 4, Part 1, entry for Cyproheptadine

    substitute:

Cyproheptadine C5858 Prevention of migraine
  1. 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
  1. 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

  2. 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
  1. 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
  1. 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
  1. 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.
Patient must identify as Aboriginal or Torres Strait Islander.

  1. 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

  2. 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.

  1. 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

  1. 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

  2. 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
Patient must be one in whom transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance.

Compliance with Authority Required procedures
C5850

Migraine attack

The condition must have usually failed to respond to analgesics in the past; AND
Patient must be one in whom transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences.

Compliance with Authority Required procedures
C5859

Migraine attack

The condition must have usually failed to respond to analgesics in the past; AND
Patient must be one in whom adverse events have occurred with other suitable PBS-listed drugs.

Compliance with Authority Required procedures
C5860

Migraine attack

The condition must have usually failed to respond to analgesics in the past; AND
Patient must be one in whom drug interactions are expected to occur with other suitable PBS-listed drugs.

Compliance with Authority Required procedures
C5887

Migraine attack

The condition must have usually failed to respond to analgesics in the past; AND
Patient must be one in whom drug interactions have occurred with other suitable PBS-listed drugs.

Compliance with Authority Required procedures
  1. 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
  1. 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

  2. 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

  1. 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.
  1. 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

  2. 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
  1. 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.

  1. 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
Patient must have been treated with this drug for this condition prior to 1 January 2016; 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.
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) positivity.

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
  1. Schedule 4, Part 1, entry for Triglycerides, medium chain

    (a)omit:

C5616

Intractable childhood epilepsy

Patient must require a ketogenic diet.
Cerebrospinal fluid glucose transporter defect
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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