National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 2) (PB 11 of 2016) (Cth)

Case

PB 11 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 2)

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    19 February 2016

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 2016 (No. 2).

(2)        This Instrument may also be cited as PB 11 of 2016.

2          Commencement

This Instrument commences on 1 March 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. Section 4

    insert after the definition of “extemporaneously‑prepared pharmaceutical benefit”:

    General Statement for drugs for the treatment of hepatitis C means the statement set out in Part 3 of Schedule 4;

  2. Schedule 1, entry for Aciclovir

    substitute:

Aciclovir Eye ointment 30 mg per g, 4.5 g Application to the eye AciVision DZ MP NP C5965 1 0 1
AO C5964 1 0 1
Zovirax GK MP NP C5965 1 0 1
AO C5964 1 0 1
Tablet 200 mg Oral a Aciclovir Sandoz HX MP NP C5936 C5942 P5936 50 0 25
a Acyclo‑V 200 AF MP NP C5936 C5942 P5936 50 0 25
a GenRx Aciclovir GX MP NP C5936 C5942 P5936 50 0 50
a Lovir GN MP NP C5936 C5942 P5936 50 0 25
a Zovirax 200 mg GK MP NP C5936 C5942 P5936 50 0 25
a Aciclovir 200 CR MP NP C5942 90 5 90
a Aciclovir GH GQ MP NP C5942 90 5 90
a Aciclovir Sandoz HX MP NP C5936 C5942 P5942 90 5 90
a Acyclo‑V 200 AF MP NP C5936 C5942 P5942 90 5 90
a Chem mart Aciclovir CH MP NP C5942 90 5 90
a GenRx Aciclovir GX MP NP C5936 C5942 P5942 90 5 90
a Lovir GN MP NP C5936 C5942 P5942 90 5 90
a Ozvir RA MP NP C5942 90 5 90
a Terry White Chemists Aciclovir TW MP NP C5942 90 5 90
a Zovirax 200 mg GK MP NP C5936 C5942 P5942 90 5 90
Tablet 800 mg Oral a Aciclovir 800 CR MP NP C5959 C5967 35 0 35
a Aciclovir Sandoz HX MP NP C5959 C5967 35 0 35
a Acyclo‑V 800 AF MP NP C5946 C5959 C5967 P5959 P5967 35 0 35
a GenRx Aciclovir GX MP NP C5959 C5967 35 0 35
a Zovirax 800 mg GK MP NP C5959 C5967 35 0 35
Acyclo‑V 800 AF MP NP C5946 C5959 C5967 P5946 120 5 120

  1. Schedule 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid

    insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine Bottles containing oral powder 34 g, 30 (PKU Easy Shake & Go) Oral PKU Easy Shake & Go OH MP NP C5970 4 5 1

  1. Schedule 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

    insert in numerical order in the column headed “Circumstances”:         C5945  C5974

  2. Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides in the form Oral powder 400 g (Alfamino)

    insert in numerical order in the column headed “Circumstances”:         C4415  C5945  C5974

  3. Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

    omit from the column headed “Responsible Person” for the brand “Rithmik 200”:            QA       substitute:             RW

  4. Schedule 1, entry for Amisulpride in the form Tablet 400 mg

    omit from the column headed “Responsible Person” for the brand “Amipride 400”:          QA       substitute:             RW

  5. Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)

    omit:

Amlodipine‑DRLA RZ MP NP 30 5 30

  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)

    (a)omit:

a Clamoxyl Duo AL PDP C5833 C5894 10 0 10

(b)omit:

a Clamoxyl Duo AL MP NP MW C5832 C5893 10 1 10

  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)

    (a)omit:

a Clamoxyl Duo forte AL PDP C5833 C5894 10 0 10

(b)omit:

a Clamoxyl Duo forte AL MP NP C5832 C5893 10 1 10

  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

    (a)omit:

Clamoxyl AL PDP C5833 C5894 1 0 1

(b)omit:

Clamoxyl AL MP NP C5832 C5893 1 1 1

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL

    (a)omit:

Clamoxyl Duo 400 AL PDP C5833 C5894 1 0 1

(b)omit:

Clamoxyl Duo 400 AL MP NP C5832 C5893 1 1 1

  1. Schedule 1, entry for Anastrozole

    (a)omit:

Anastrozole‑DRLA RZ MP NP C5464 30 5 30

(b)omit:

Pharmacy Choice Anastrozole RI MP NP C5464 30 5 30

  1. Schedule 1, entry for Atenolol in the form Tablet 50 mg

    omit from the column headed “Responsible Person” for the brand “Tensig”:      QA       substitute:             RW

  2. Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium)

    omit from the column headed “Responsible Person” for the brands “Torvastat 10”, “Torvastat 20”, “Torvastat 40” and “Torvastat 80” respectively (all instances):  QA       substitute:             RW

  3. Schedule 1, entry for Azathioprine in the form Tablet 50 mg

    omit from the column headed “Responsible Person” for the brand “Azapin”:      QA       substitute:             RW

  4. Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms [Maximum Quantity: 2; Number of Repeats: 0]

    (a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a APO-Cabergoline TX MP C5136 C5137 C5357 C5172 C5398 P5172 2 0 2
NP C5172 2 0 2

(b)insert in the column headed “Schedule Equivalent” for the brands “Dostan” and “Dostinex”:            a

  1. Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms [Maximum Quantity: 8; Number of Repeats: 5]

    (a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a APO-Cabergoline TX MP C5136 C5137 C5357 C5172 C5398 P5136 P5137 P5357 P5398 8 5 8

(b)insert in the column headed “Schedule Equivalent” for the brands “Dostan” and “Dostinex”:            a

  1. Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

    omit from the column headed “Circumstances”:          C3827   substitute:             C5955

  2. Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g

    omit from the column headed “Circumstances”:          C5465   substitute:             C5963

  3. Schedule 1, entry for Calcitriol

    omit from the column headed “Responsible Person” for the brand “Kosteo”:      QA       substitute:             RW

  4. Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg

    omit from the column headed “Responsible Person” for the brands “Candesartan Aspen 4”, “Candesartan Aspen 8”, “Candesartan Aspen 16” and “Candesartan Aspen 32” respectively:
    QA        substitute:             RW

  5. Schedule 1, entry for Candesartan with Hydrochlorothiazide in each of the forms: Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg; Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg; and Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

    omit from the column headed “Responsible Person” for the brands “Candesartan Combi Aspen 16/12.5”, “Candesartan Combi Aspen 32/12.5” and
    “Candesartan Combi Aspen 32/25” respectively:           QA       substitute:             RW

  6. Schedule 1, entry for Carmustine

    omit from the column headed “Responsible Person”:                 OA       substitute:             EI

  7. Schedule 1, entry for Carvedilol in each of the forms: Tablet 3.125 mg; Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg

    omit from the column headed “Responsible Person” for the brands “Vedilol 3.125”, “Vedilol 6.25”, “Vedilol 12.5” and “Vedilol 25” respectively:
    QA        substitute:             RW

  8. Schedule 1, entry for Celecoxib in each of the forms: Capsule 100 mg; and Capsule 200 mg

    omit from the column headed “Responsible Person” for the brand “Celexi”:       QA       substitute:             RW

  9. Schedule 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)

    omit:

Ciprofloxacin‑
DRLA 		RZ MP NP C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780 14 0 14

  1. Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

    omit:

Ciprofloxacin‑
DRLA 		RZ MP NP C5614 C5615 C5687 C5688 C5689 C5722 C5780 14 0 14

  1. Schedule 1, entry for Citalopram in each of the forms: Tablet 10 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)

    omit from the column headed “Responsible Person” for the brand “Talam”:       QA       substitute:             RW

  2. Schedule 1, entry for Clindamycin

    omit from the column headed “Responsible Person” for the brand “Calindamin”:             QA       substitute:             RW

  3. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

    (a)omit from the column headed “Responsible Person” for the brand “Clovix 75”:      QA       substitute:             RW

    (b)omit from the column headed “Responsible Person” for the brand “Plidogrel”:      FM       substitute:             RF

  4. Schedule 1, after entry for Dabrafenib in the form Capsule 75 mg (as mesilate)

    insert:

Daclatasvir Tablet 30 mg Oral Daklinza BQ MP C5969 C5972 P5969 28 2 28
MP C5969 C5972 P5972 28 5 28
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100)
Tablet 60 mg Oral Daklinza BQ MP C5969 C5972 P5969 28 2 28
MP C5969 C5972 P5972 28 5 28
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100)

  1. Schedule 1, entry for Diclofenac in each of the forms: Tablet (enteric coated) containing diclofenac sodium 25 mg; and Tablet (enteric coated) containing diclofenac sodium 50 mg

    omit from the column headed “Responsible Person” for the brands “Clonac 25” and “Clonac 50” respectively:      QA            substitute:             RW

  2. Schedule 1, entry for Dipyridamole with Aspirin

    omit from the column headed “Responsible Person” for the brand “Diasp SR”:                  QA       substitute:             RW

  3. Schedule 1, entry for Doxorubicin – Pegylated Liposomal in each of the forms: Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL; and Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride
    50 mg in 25 mL

    omit from the column headed “Responsible Person” for the brand “Liposomal Doxorubicin SUN”:              ZF        substitute:                RA

  4. Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as monohydrate)

    omit from the column headed “Responsible Person” for the brand “Frakas”:   QA       substitute:             RW

  5. Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

    (a)insert in the column headed “Schedule Equivalent” for all brands:             a

    (b)omit:

a Duloxetine-DRLA RZ MP NP C1211 28 0 28

(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Duloxetine Sandoz HX MP NP C1211 28 0 28

  1. Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

    (a)insert in the column headed “Schedule Equivalent” for all brands:             a

    (b)omit:

a Duloxetine-DRLA RZ MP NP C1211 28 5 28

(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Duloxetine Sandoz HX MP NP C1211 28 5 28

  1. Schedule 1, entry for Empagliflozin in each of the forms: Tablet 10 mg; and Tablet 25 mg

    omit from the column headed “Circumstances”:          C4848   substitute:             C4983  C4991  C5629

  2. Schedule 1, after entry for Empagliflozin in the form Tablet 25 mg

    insert:

Empagliflozin with metformin Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride Oral Jardiamet 5 mg/1000 mg BY MP C5657 C5798 C5953 C5966 60 5 60
NP C5657 C5798 C5966 60 5 60
Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride Oral Jardiamet 5 mg/500 mg BY MP C5657 C5798 C5953 C5966 60 5 60
NP C5657 C5798 C5966 60 5 60
Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride Oral Jardiamet 12.5 mg/1000 mg BY MP C5657 C5798 C5953 C5966 60 5 60
NP C5657 C5798 C5966 60 5 60
Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride Oral Jardiamet 12.5 mg/500 mg BY MP C5657 C5798 C5953 C5966 60 5 60
NP C5657 C5798 C5966 60 5 60

  1. Schedule 1, entry for Famciclovir

    substitute:

Famciclovir Tablet 125 mg Oral a APO‑Famciclovir TX MP NP C5937 40 1 40
a Auro-Famciclovir 125 DO MP NP C5937 40 1 40
a Ezovir AF MP NP C5937 40 1 40
a Famciclovir AN EA MP NP C5937 40 1 40
a Famciclovir‑GA ED MP NP C5937 40 1 40
a Famvir NV MP NP C5937 40 1 40
a Favic 125 QA MP NP C5937 40 1 40
Tablet 250 mg Oral a APO‑Famciclovir TX MP NP C5937 C5951 C5971 P5937 20 1 20
a Ezovir AF MP NP C5937 C5951 C5971 P5937 20 1 20
a Famciclovir AN EA MP NP C5937 C5951 C5971 P5937 20 1 20
a Famciclovir‑GA ED MP NP C5937 C5951 C5971 P5937 20 1 20
a Famciclovir Sandoz SZ MP NP C5937 C5951 C5971 P5937 20 1 20
a Famvir NV MP NP C5937 C5951 C5971 P5937 20 1 20
a Favic 250 QA MP NP C5937 C5951 C5971 P5937 20 1 20
a APO‑Famciclovir TX MP NP C5937 C5951 C5971 P5951 21 0 21
a Auro-Famciclovir 250 DO MP NP C5951 C5971 P5951 21 0 21
a Ezovir AF MP NP C5937 C5951 C5971 P5951 21 0 21
a Famciclovir AN EA MP NP C5937 C5951 C5971 P5951 21 0 21
a Famciclovir‑GA ED MP NP C5937 C5951 C5971 P5951 21 0 21
a Famciclovir generichealth 250 GQ MP NP C5951 C5971 P5951 21 0 21
a Famciclovir Sandoz SZ MP NP C5937 C5951 C5971 P5951 21 0 21
a Famciclovir SCP 250 CR MP NP C5951 C5971 P5951 21 0 21
a Famlo RA MP NP C5951 C5971 P5951 21 0 21
a Famvir NV MP NP C5937 C5951 C5971 P5951 21 0 21
a Favic 250 QA MP NP C5937 C5951 C5971 P5951 21 0 21
a APO‑Famciclovir TX MP NP C5937 C5951 C5971 P5971 56 5 56
a Auro-Famciclovir 250 DO MP NP C5951 C5971 P5971 56 5 56
a Ezovir AF MP NP C5937 C5951 C5971 P5971 56 5 56
a Famciclovir AN EA MP NP C5937 C5951 C5971 P5971 56 5 56
a Famciclovir‑GA ED MP NP C5937 C5951 C5971 P5971 56 5 56
a Famciclovir generichealth 250 GQ MP NP C5951 C5971 P5971 56 5 56
a Famciclovir Sandoz SZ MP NP C5937 C5951 C5971 P5971 56 5 56
a Famciclovir SCP 250 CR MP NP C5951 C5971 P5971 56 5 56
a Famlo RA MP NP C5951 C5971 P5971 56 5 56
a Famvir NV MP NP C5937 C5951 C5971 P5971 56 5 56
a Favic 250 QA MP NP C5937 C5951 C5971 P5971 56 5 56
Tablet 500 mg Oral a APO‑Famciclovir TX MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30
a Auro-Famciclovir 500 DO MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30
a Chem mart Famciclovir CH MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30
a Famciclovir AN EA MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30
a Famciclovir Sandoz SZ MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30
a Famvir NV MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30
a Favic 500 QA MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30
a Terry White Chemists Famciclovir TW MP NP C5943 C5947 C5948 C5949 C5954 P5943 30 0 30
a APO‑Famciclovir TX MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56
a Auro-Famciclovir 500 DO MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56
a Chem mart Famciclovir CH MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56
a Ezovir AF MP NP C5947 C5948 C5949 C5954 56 5 56
a Famciclovir AN EA MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56
a Famciclovir‑GA ED MP NP C5947 C5948 C5949 C5954 56 5 56
a Famciclovir generichealth 500 GQ MP NP C5947 C5948 C5949 C5954 56 5 56
a Famciclovir Sandoz SZ MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56
a Famvir NV MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56
a Favic 500 QA MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56
a Terry White Chemists Famciclovir TW MP NP C5943 C5947 C5948 C5949 C5954 P5947 P5948 P5949 P5954 56 5 56

  1. Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg

    omit from the column headed “Responsible Person” for the brands “Faverin 50” and “Faverin 100” respectively:                  QA            substitute:             RW

  1. Schedule 1, entry for Folinic acid in the form Tablet containing calcium folinate equivalent to 15 mg folinic acid

    substitute:

Tablet containing calcium folinate equivalent to 15 mg folinic acid Oral Leucovorin Calcium (Hospira Pty Limited) HH MP C5938 10 0 10
MP C5973 10 0 10 C(100)

  1. Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)

    omit from the column headed “Responsible Person” for the brand “Gamine XR”:              QA       substitute:             RW

  2. Schedule 1, entry for Gemcitabine in each of the forms: Powder for I.V. infusion 200 mg (as hydrochloride); and Powder for I.V. infusion 1 g (as hydrochloride)

    omit from the column headed “Responsible Person” for the brand “Gemcitabine Sun”:   ZF        substitute:             RA

  3. Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk)

    insert in the columns in the order indicated:

Sachets containing oral powder 49 g, 30 (Camino Pro Bettermilk) Oral Camino Pro Bettermilk QH MP NP C4295 4 5 1

  1. Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg

    omit:

Irbesartan-DRLA RZ MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in each of the forms: Tablet 150 mg-12.5 mg; Tablet 300 mg-12.5 mg; and Tablet 300 mg-25 mg

    omit from the column headed “Responsible Person” for the brands “KSART HCT 150/12.5”, “KSART HCT 300/12.5” and “KSART HCT 300/25” respectively:               QA       substitute:             RW

  2. Schedule 1, entry for Lamotrigine in each of the forms: Tablet 5 mg; Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

    omit:

Lamogine AF MP NP C5138 56 5 56

  1. Schedule 1, after entry for Latanoprost with timolol [Brand: Xamalol 50/5]

    insert:

Ledipasvir with sofosbuvir Tablet containing 90 mg ledipasvir with 400 mg sofosbuvir Oral Harvoni GI MP C5944 C5969 C5972 P5944 28 1 28
MP C5944 C5969 C5972 P5969 28 2 28
MP C5944 C5969 C5972 P5972 28 5 28
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100)

  1. Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 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 Leflunomide APOTEX GX MP C5681 C5766 30 5 30

  1. Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg

    omit from the column headed “Responsible Person” for the brand “Lercan”:      QA       substitute:             RW

  2. Schedule 1, entry for Letrozole

    (a)omit:

Letrozole‑DRLA RZ MP NP C5464 30 5 30

(b)omit:

Pharmacy Choice Letrozole RI MP NP C5464 30 5 30

  1. Schedule 1, after entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate
    30 mg with diluent in pre-filled dual-chamber syringe

    insert in the columns in the order indicated:

I.M. injection (modified release), powder for injection containing leuprorelin acetate 45 mg with diluent in pre-filled dual-chamber syringe Injection Lucrin Depot 6-Month VE MP C5646 1 0 1

  1. Schedule 1, entry for Levetiracetam in the form Tablet 250 mg

    omit from the column headed “Responsible Person” for the brand “Levi 250”:   FM       substitute:             RW

  2. Schedule 1, entry for Levetiracetam in the form Tablet 500 mg

    (a)insert in the column headed “Schedule Equivalent” for all brands:             a

    (b)omit from the column headed “Brand”:               Levetiracetam generichealth     substitute:             Levetiracetam GH

    (c)omit from the column headed “Responsible Person” for the brand “Levi 500”:                        FM       substitute:             RW

  3. Schedule 1, entry for Levetiracetam in the form Tablet 1 g

    omit from the column headed “Responsible Person” for the brand “Levi 1000”:   FM       substitute:             RW

  4. Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg

    omit:

Lisinopril‑DRLA RZ MP NP 30 5 30

  1. Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30

    (a)omit from the column headed “Responsible Person” for the brand “Chemists’ Own Macrogol with Electrolytes” (all instances): 
    FM            substitute:             RW

    (b)omit from the column headed “Responsible Person” for the brand “Macrovic” (all instances):            QA       substitute:      RF

  2. Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 10 mg

    omit from the column headed “Responsible Person” for the brand “Memanxa”:                 QA       substitute:             RW

  1. Schedule 1, entry for Metformin in each of the forms: Tablet containing metformin hydrochloride 500 mg; and Tablet containing metformin hydrochloride 850 mg

    omit from the column headed “Responsible Person” for the brands “Formet Aspen 500” and “Formet Aspen 850” respectively:      AS    substitute:                  RW

  2. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

    (a)omit:

Metatar FM MP NP 100 5 100

(b)omit from the column headed “Responsible Person” for the brand “Metrol 50”:      QA       substitute:             RW

(c)omit:

Metatar FM MP NP 60 5 60

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

    (a)omit:

Metatar FM MP NP 60 5 60

(b)omit from the column headed “Responsible Person” for the brand “Metrol 100”:   QA       substitute:             RW

  1. Schedule 1, entry for Metoprolol succinate in each of the forms: Tablet 23.75 mg (controlled release); Tablet 47.5 mg (controlled release); Tablet 95 mg (controlled release); and Tablet 190 mg (controlled release)

    omit from the column headed “Responsible Person” for the brands “Metrol-XL 23.75”, “Metrol-XL 47.5”, “Metrol-XL 95” and “Metrol-XL 190” respectively:
    QA        substitute:             RW

  2. Schedule 1, entry for Mirtazapine in each of the forms: Tablet 30 mg; and Tablet 45 mg

    omit from the column headed “Responsible Person” for the brand “Mirtazon”: QA       substitute:             RW

  3. Schedule 1, entry for Montelukast in each of the forms: Tablet, chewable, 4 mg (as sodium); and Tablet, chewable, 5 mg (as sodium)

    omit from the column headed “Responsible Person” for the brands “Respikast 4” and “Respikast 5” respectively:
    QA        substitute:             RW

  1. Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 10 mg (controlled release); Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)

    omit from the column headed “Responsible Person” for the brands “Momex SR 10”, “Momex SR 30”, “Momex SR 60” and “Momex SR 100” respectively:
    QA        substitute:             RW

  2. Schedule 1, entry for Nifedipine in each of the forms: Tablet 30 mg (controlled release); and Tablet 60 mg (controlled release)

    omit from the column headed “Responsible Person” for the brands “Addos XR 30” and “Addos XR 60” respectively:              QA            substitute:             RW

  3. Schedule 1, entry for Nitrazepam

    omit:

Alodorm AF MP NP P5661 P5684 P5770 P5771 50
CN5661 CN5684  CN5770 CN5771 		5
CN5661 CN5684 CN5770 CN5771 		25
Mogadon IA MP NP P5661 P5684 P5770 P5771 50
CN5661 CN5684 CN5770 CN5771 		5
CN5661 CN5684 CN5770 CN5771 		25

substitute:

a Alodorm AF MP NP P5661 P5771 P5941 P5950 50
CN5661 CN5771 CN5941 CN5950 		5
CN5661 CN5771 CN5941 CN5950 		25
a Mogadon IA MP NP P5661 P5771 P5941 P5950 50
CN5661 CN5771 CN5941 CN5950 		5
CN5661 CN5771 CN5941 CN5950 		25

  1. Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL

    omit from the column headed “Responsible Person” for the brand “Octreotide (SUN)”:   ZF        substitute:             RA

  2. Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg

    (a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzacor 2.5 CR MP NP C5856 C5869 28 5 28

(b)omit:

Pharmacor Olanzapine 2.5 CR MP NP C5856 C5869 28 5 28

(c)omit:

Pharmacy Choice Olanzapine RI MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 5 mg

    (a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzacor 5 CR MP NP C5856 C5869 28 5 28

(b)omit:

Pharmacor Olanzapine 5 CR MP NP C5856 C5869 28 5 28

(c)omit:

Pharmacy Choice Olanzapine RI MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg

    (a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzacor 7.5 CR MP NP C5856 C5869 28 5 28

(b)omit:

Pharmacor Olanzapine 7.5 CR MP NP C5856 C5869 28 5 28

(c)omit:

Pharmacy Choice Olanzapine RI MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 10 mg

    (a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzacor 10 CR MP NP C5856 C5869 28 5 28

(b)omit:

Pharmacor Olanzapine 10 CR MP NP C5856 C5869 28 5 28

(c)omit:

Pharmacy Choice Olanzapine RI MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)

    omit:

Pharmacy Choice Olanzapine ODT RI MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Omeprazole in the form Capsule 20 mg

    omit from the column headed “Responsible Person” for the brand “Pemzo” (twice occurring):      QA       substitute:             RW

  2. Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL

    omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”:    ZF        substitute:             RA

  3. Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

    (a)omit:

Oxaliplatin MYX YN MP See Note 3 See
Note 3 		1 D(100)

(b)omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”:                         ZFsubstitute:      RA

  1. Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 200 mg in 40 mL

    omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”:    ZF        substitute:             RA:

  2. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

    omit:

Indopril 2 QA MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

    omit:

Indopril 4 QA MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

    omit:

Indopril 8 QA MP NP 30 5 30

  1. Schedule 1, entry for Phenoxybenzamine in the form Capsules containing phenoxybenzamine hydrochloride 10 mg, 30

    omit from the column headed “Brand”:         Dibenyline        substitute:             Amdipharm Mercury (Australia) Pty Limited

  2. Schedule 1, entry for Pramipexole in each of the forms: Tablet (extended release) containing pramipexole hydrochloride 375 micrograms; Tablet (extended release) containing pramipexole hydrochloride 750 micrograms; Tablet (extended release) containing pramipexole hydrochloride 1.5 mg; Tablet (extended release) containing pramipexole hydrochloride 2.25 mg; Tablet (extended release) containing pramipexole hydrochloride 3 mg; Tablet (extended release) containing pramipexole hydrochloride 3.75 mg; and Tablet (extended release) containing pramipexole hydrochloride 4.5 mg

(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a APO-Pramipexole ER TX MP NP C5131 30 5 30

(b)insert in the column headed “Schedule Equivalent” for the brand “Sifrol ER” (all instances):             a

  1. Schedule 1, after entry for Propylthiouracil

    insert:

Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid Oral liquid 130 mL, 30 (PKU Easy) Oral PKU Easy OH MP NP C5970 4 5 1

  1. Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

    (a)omit:

Pharmacy Choice Quetiapine RI MP NP C4385 C4391 C4396 60 0 60

(b)omit from the column headed “Responsible Person” for the brand “Quetia 25”:      FM       substitute:             RW

(c)omit from the column headed “Responsible Person” for the brand “Seronia 25”:    QAsubstitute:             RF

  1. Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

    (a)omit:

Pharmacy Choice Quetiapine RI MP NP C4246 C5611 C5639 90 5 90

(b)omit from the column headed “Responsible Person” for the brand “Quetia 100”:   FM       substitute:             RW

  1. Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)

    (a)omit:

Pharmacy Choice Quetiapine RI MP NP C4246 C5611 C5639 60 5 60

(b)omit from the column headed “Responsible Person” for the brands “Quetia 200” and “Quetia 300” respectively:         FM    substitute:             RW

  1. Schedule 1, entry for Rabeprazole in each of the forms: Tablet containing rabeprazole sodium 10 mg (enteric coated); and Tablet containing rabeprazole sodium 20 mg (enteric coated)

    omit from the column headed “Responsible Person” for the brand “Parbezol”:                  QA       substitute:             RW

  2. Schedule 1, entry for Ramipril in each of the forms: Tablet 2.5 mg; Tablet 5 mg; and Capsule 10 mg

    omit from the column headed “Responsible Person” for the brands “Prilace 2.5”, “Prilace 5” and “Prilace 10” respectively:                QA       substitute:             RW

  3. Schedule 1, after entry for Reteplase

    insert:

Ribavirin Tablet 400 mg Oral Ibavyr IX MP C5957 C5958 P5957 28 2 28
MP C5957 C5958 P5958 28 5 28
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100)
Tablet 600 mg Oral Ibavyr IX MP C5957 C5958 P5957 28 2 28
MP C5957 C5958 P5958 28 5 28
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100)

  1. Schedule 1, entry for Ribavirin and Peginterferon Alfa-2a

    substitute:

Ribavirin and Peginterferon Alfa‑2a Pack containing 168 tablets ribavirin 200 mg and 4 pre‑filled syringes peginterferon alfa‑2a injection 135 micrograms Injection/
oral 		Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 2 5 1 PB(100)
Pack containing 112 tablets ribavirin 200 mg and 4 pre‑filled syringes peginterferon alfa‑2a injection 180 micrograms Injection/
oral 		Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 2 5 1 PB(100)
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P5956 1 2 1
MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P4184 P4185 P4187 P4188 P4193 P4197 P4206 P4207 2 5 1 C(100)
Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P5956 1 2 1
MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P4184 P4185 P4187 P4188 P4193 P4197 P4206 P4207 2 5 1 C(100)

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg

    (a)omit:

Risperidone‑DRLA RZ MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60

(b)omit:

Risperidone‑DRLA RZ MP NP C5902 C5903 C5908 C5911 P5903 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg

    (a)omit:

Risperidone‑DRLA RZ MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60

(b)omit:

Risperidone‑DRLA RZ MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg

    (a)omit:

Risperidone‑DRLA RZ MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60

(b)omit:

Risperidone‑DRLA RZ MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 3 mg

    omit:

Risperidone‑DRLA RZ MP NP C4246 C5907 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 4 mg

    omit:

Risperidone‑DRLA RZ MP NP C4246 C5907 60 5 60

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

    (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 Rosuvastatin AMNEAL EF MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

    (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 Rosuvastatin AMNEAL EF MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

    (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 Rosuvastatin AMNEAL EF MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

    (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 Rosuvastatin AMNEAL EF MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

    (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 Rosuvastatin AMNEAL EF MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

    (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 Rosuvastatin AMNEAL EF MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

    (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 Rosuvastatin AMNEAL EF MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

    (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 Rosuvastatin AMNEAL EF MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)

    omit:

Sertraline‑DRLA RZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Simeprevir

    omit from the column headed “Circumstances”:          C4758  C4759

  2. Schedule 1, entry for Simvastatin in the form Tablet 10 mg

    (a)omit:

Simvastatin‑DRLA RZ MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Simvastatin‑DRLA RZ MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg

    (a)omit:

Simvastatin‑DRLA RZ MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Simvastatin‑DRLA RZ MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg

    (a)omit:

Simvastatin‑DRLA RZ MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Simvastatin‑DRLA RZ MP C1540 C3047 P3407 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg

    (a)omit:

Simvastatin‑DRLA RZ MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Simvastatin‑DRLA RZ MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, after entry for Sodium Lactate Compound

    insert:

Sofosbuvir Tablet 400 mg Oral Sovaldi GI MP C5969 C5972 P5969 28 2 28
MP C5969 C5972 P5972 28 5 28
MP See Note 2 See Note 2 See Note 2 See Note 2 28 C(100)

  1. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

    (a)omit:

Sumatab AF MP NP C5259 4 5 2

(b)omit from the column headed “Responsible Person” for the brand “Sumatran” (twice occurring):      QA       substitute:      OW

  1. Schedule 1, entry for Temazepam

    omit:

APO‑Temazepam TX MP NP P5661 P5684 P5770 50
CN5661 CN5684 CN5770 		5
CN5661 CN5684 CN5770 		25
Normison QA MP NP P5661 P5684 P5770 50
CN5661 CN5684 CN5770 		5
CN5661 CN5684 CN5770 		25
Temaze AF MP NP P5661 P5684 P5770 50
CN5661 CN5684 CN5770 		5
CN5661 CN5684 CN5770 		25
Temtabs FM MP NP P5661 P5684 P5770 50
CN5661 CN5684 CN5770 		5
CN5661 CN5684 CN5770 		25

substitute:

APO‑Temazepam TX MP NP P5661 P5941 P5950 50
CN5661 CN5941 CN5950 		5
CN5661 CN5941 CN5950 		25
Normison QA MP NP P5661 P5941 P5950 50
CN5661 CN5941 CN5950 		5
CN5661 CN5941 CN5950 		25
Temaze AF MP NP P5661 P5941 P5950 50
CN5661 CN5941 CN5950 		5
CN5661 CN5941 CN5950 		25
Temtabs FM MP NP P5661 P5941 P5950 50
CN5661 CN5941 CN5950 		5
CN5661 CN5941 CN5950 		25

  1. Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

    (a)omit:

Pharmacy Choice Terbinafine RI MP NP C2191 C2865 C3244 P2865 P3244 42 0 42

(b)omit:

Pharmacy Choice Terbinafine RI MP NP C2191 C2865 C3244 P2191 42 1 42

  1. Schedule 1, entry for Ursodeoxycholic Acid

    (a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Ursodox GH GQ MP NP C5757 200 2 100

(b)insert in the column headed “Schedule Equivalent” for the brands “Ursofalk” and “Ursosan”:          a

  1. Schedule 1, entry for Valaciclovir

    substitute:

Valaciclovir Tablet 500 mg (as hydrochloride) Oral a APO‑Valaciclovir TX MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10
a Vaclovir AF MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10
a Valaciclovir Actavis ED MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10
a Valaciclovir AN EA MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10
a Valaciclovir GA GN MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10
a Valaciclovir Sandoz SZ MP NP C5960 C5961 C5962 C5968 P5960 20 0 10
a Valnir QA MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10
a Valtrex AS MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10
a Zelitrex FM MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10
a APO‑Valaciclovir TX MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30
a Chem mart Valaciclovir CH MP NP C5940 C5961 C5962 C5968 P5940 P5961 30 5 30
a Shilova 500 DO MP NP C5940 C5961 30 5 30
a Terry White Chemists Valaciclovir TW MP NP C5940 C5961 C5962 C5968 P5940 P5961 30 5 30
a Vaclovir AF MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30
a Valaciclovir Actavis ED MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30
a Valaciclovir AN EA MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30
a Valaciclovir GA GN MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30
a Valaciclovir generichealth GQ MP NP C5940 C5961 C5962 C5968 P5940 P5961 30 5 30
a Valaciclovir RBX RA MP NP C5940 C5961 C5962 C5968 P5940 P5961 30 5 30
a Valaciclovir Sandoz SZ MP NP C5960 C5961 C5962 C5968 P5961 30 5 30
a Valaciclovir SZ HX MP NP C5940 C5961 30 5 30
a Valacor 500 CR MP NP C5940 C5961 C5962 C5968 P5940 P5961 30 5 30
a Valnir QA MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30
a Valtrex AS MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30
a Zelitrex FM MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30
a APO‑Valaciclovir TX MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a Chem mart Valaciclovir CH MP NP C5940 C5961 C5962 C5968 P5962 P5968 42 0 42
a Terry White Chemists Valaciclovir TW MP NP C5940 C5961 C5962 C5968 P5962 P5968 42 0 42
a Vaclovir AF MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valaciclovir Actavis ED MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valaciclovir AN EA MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valaciclovir GA GN MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valaciclovir generichealth GQ MP NP C5940 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valaciclovir RBX RA MP NP C5940 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valaciclovir Sandoz SZ MP NP C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valacor 500 CR MP NP C5940 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valnir QA MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a Valtrex AS MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a Zelitrex FM MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42
a APO‑Valaciclovir TX MP C5939 C5975 500 2 100 C(100)
a Valaciclovir RBX RA MP C5939 C5975 500 2 100 C(100)
a Valtrex AS MP C5939 C5975 500 2 100 C(100)
a Zelitrex FM MP C5939 C5975 500 2 100 C(100)

  1. Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 0]

    insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Vttack AF MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56

  1. Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 2]

    insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Vttack AF MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 P5748 56 2 56

  1. Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 0]

    insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Vttack AF MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56

  1. Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 2]

    insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

a Vttack AF MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 P5748 56 2 56

  1. Schedule 1, entry for Zolmitriptan

    omit from the column headed “Responsible Person” for the brand “Zoltrip”:   QA       substitute:             RW

  2. Schedule 3, after details relevant to Responsible Person code OE

    insert:

OH Orpharma Pty Ltd  19 157 901 267

  1. Schedule 3

    omit:

ZF Sun Pharmaceutical Industries (Australia) Pty Ltd  64 130119603

  1. Schedule 4, Part 1, entry for Aciclovir

    substitute:

Aciclovir C5936 P5936

Initial moderate to severe genital herpes

Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5936
C5942 P5942

Recurrent moderate to severe genital herpes

Episodic treatment or suppressive therapy

Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5942
C5946 P5946

Advanced human immunodeficiency virus (HIV) disease

Patient must have CD4 cell counts of less than 150 million per litre.

 Compliance with Authority Required procedures - Streamlined Authority Code 5946
C5959 P5959 Herpes zoster ophthalmicus Compliance with Authority Required procedures - Streamlined Authority Code 5959
C5964 Herpes simplex keratitis
C5965 Herpes simplex keratitis
C5967 P5967

Herpes zoster

The treatment must be administered within 72 hours of the onset of the rash.

 Compliance with Authority Required procedures - Streamlined Authority Code 5967

  1. Schedule 4, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid

    insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine C5970 Phenylketonuria

  1. Schedule 4, Part 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

    insert in numerical order:

C5945

Eosinophilic oesophagitis

Initial treatment for up to 3 months

Patient must require an amino acid based formula as a component of a dietary elimination program.
Patient must be 18 years of age or less.
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Treatment with oral steroids should not be commenced during the period of initial treatment.
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
The date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C5974

Eosinophilic oesophagitis

Continuing treatment

Patient must have responded to an initial course of PBS-subsidised treatment.
Patient must be 18 years of age or less.
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

    insert in numerical order:

C4415

Severe intestinal malabsorption including short bowel syndrome

Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition.

 Compliance with Authority Required procedures
C5945

Eosinophilic oesophagitis

Initial treatment for up to 3 months

Patient must require an amino acid based formula as a component of a dietary elimination program.
Patient must be 18 years of age or less.
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Treatment with oral steroids should not be commenced during the period of initial treatment.
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
The date of birth of the patient must be included in the authority application.

 Compliance with Authority Required procedures
C5974

Eosinophilic oesophagitis

Continuing treatment

Patient must have responded to an initial course of PBS-subsidised treatment.
Patient must be 18 years of age or less.
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Calcipotriol with betamethasone

    (a)omit:

C3827 Chronic stable plaque type psoriasis vulgaris of the scalp in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy
C5465 P5465 CN5465

Chronic stable plaque type psoriasis vulgaris

The condition must be on the patient's scalp; AND
The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; AND
Patient must require more than 30 grams of the product per month.

 Compliance with Authority Required procedures - Streamlined Authority Code 5465

(b)insert in numerical order after existing text:

C5955

Chronic stable plaque type psoriasis vulgaris

The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy.
C5963

Chronic stable plaque type psoriasis vulgaris

The condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; AND
Patient must require more than 30 grams of product per month.

 Compliance with Authority Required procedures - Streamlined Authority Code 5963

  1. Schedule 4, Part 1, after entry for Dabrafenib

    insert:

Daclatasvir C5969 P5969

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.

 Compliance with Written or Telephone Authority Required procedures
C5972 P5972

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Empagliflozin

    substitute:

Empagliflozin C4983

Diabetes mellitus type 2

The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 4983
C4991

Diabetes mellitus type 2

The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 4991
C5629

Diabetes mellitus type 2

The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.

 Compliance with Authority Required procedures - Streamlined Authority Code 5629

  1. Schedule 4, Part 1, after entry for Empagliflozin

    insert:

Empagliflozin with metformin C5657

Diabetes mellitus type 2

The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 5657
C5798

Diabetes mellitus type 2

The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

 Compliance with Authority Required procedures - Streamlined Authority Code 5798
C5953

Diabetes mellitus type 2

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

 Compliance with Authority Required procedures - Streamlined Authority Code 5953
C5966

Diabetes mellitus type 2

Continuing treatment
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and empagliflozin.

 Compliance with Authority Required procedures - Streamlined Authority Code 5966

  1. Schedule 4, Part 1, entry for Famciclovir

    substitute:

Famciclovir C5937 P5937

Recurrent moderate to severe genital herpes

Episodic treatment

Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5937
C5943 P5943

Herpes zoster

Patient must be immunocompromised; AND
The treatment must be administered within 72 hours of the onset of the rash.

 Compliance with Authority Required procedures - Streamlined Authority Code 5943
C5947 P5947

Recurrent moderate to severe oral or labial herpes

Episodic treatment

Patient must have HIV infection; AND
Patient must have a CD4 cell count of less than 500 million per litre.
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5947
C5948 P5948

Recurrent moderate to severe oral or labial herpes

Suppressive therapy

Patient must have HIV infection; AND
Patient must have CD4 cell counts of less than 150 million per litre.
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5948
C5949 P5949

Recurrent moderate to severe oral or labial herpes

Suppressive therapy

Patient must have HIV infection; AND
Patient must present with other opportunistic infections or AIDS defining tumours.
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5949
C5951 P5951

Herpes zoster

The treatment must be administered within 72 hours of the onset of the rash.

 Compliance with Authority Required procedures - Streamlined Authority Code 5951
C5954 P5954

Recurrent moderate to severe genital herpes

Episodic treatment or suppressive therapy

Patient must be immunocompromised.
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5954
C5971 P5971

Recurrent moderate to severe genital herpes

Suppressive therapy

Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5971

  1. Schedule 4, Part 1, entry for Folinic acid

    substitute:

Folinic acid C5938

Megaloblastic anaemias

The condition must be a result of folic acid deficiency from the use of folic acid antagonists.
C5973

Megaloblastic anaemias

The condition must be a result of folic acid deficiency from the use of folic acid antagonists.

  1. Schedule 4, Part 1, after entry for Latanoprost with timolol

    insert:

Ledipasvir with sofosbuvir C5944 P5944

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 8 weeks.

 Compliance with Written or Telephone Authority Required procedures
C5969 P5969

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.

 Compliance with Written or Telephone Authority Required procedures
C5972 P5972

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Nitrazepam

    (a)omit:

P5684 CN5684

Benzodiazepine dependence

Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures
P5770 CN5770

Benzodiazepine dependence

Patient must be receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

P5941 CN5941

Insomnia

Patient must be receiving this drug for the management of insomnia; AND
Patient must be receiving long-term nursing care; AND
Patient must be one in respect of whom a Carer Allowance is payable as a disabled adult; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures
P5950 CN5950

Insomnia

Patient must be receiving this drug for the management of insomnia; AND
Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Propantheline

    insert:

Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid C5970 Phenylketonuria

  1. Schedule 4, Part 1, after entry for Reteplase

    insert:

Ribavirin C5957 P5957

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

 Compliance with Written or Telephone Authority Required procedures
C5958 P5958

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks.
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2a

    (a)insert in the column headed “Purposes Code” for Circumstances Codes C4184, C4185, C4187, C4188, C4193, C4197, C4206 and C4207 respectively:
    P4184
    P4185
    P4187
    P4188
    P4193
    P4197
    P4206
    P4207

    (b)insert in numerical order:

C5956 P5956

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Simeprevir

    (a)omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4669 and C4684:
    Where the patient is receiving treatment at/from a private hospital

    (b)omit:

C4758

Where the patient is receiving treatment at/from a public hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater

Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records

 Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4758
C4759

Where the patient is receiving treatment at/from a public hospital

Chronic genotype 1 hepatitis C infection

Patient must have compensated liver disease; AND
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater

Patient must be 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age

Must be treated in an accredited treatment centre

Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records

Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records

 Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4759

  1. Schedule 4, Part 1, after entry for Sodium Acid Phosphate

    insert:

Sofosbuvir C5969 P5969

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.

 Compliance with Written or Telephone Authority Required procedures
C5972 P5972

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks.

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Temazepam

    (a)omit:

P5684 CN5684

Benzodiazepine dependence

Patient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures
P5770 CN5770

Benzodiazepine dependence

Patient must be receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

P5941 CN5941

Insomnia

Patient must be receiving this drug for the management of insomnia; AND
Patient must be receiving long-term nursing care; AND
Patient must be one in respect of whom a Carer Allowance is payable as a disabled adult; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures
P5950 CN5950

Insomnia

Patient must be receiving this drug for the management of insomnia; AND
Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Valaciclovir

    substitute:

Valaciclovir C5939

Where the patient is receiving treatment at/from a private hospital

Cytomegalovirus infection and disease

Prophylaxis

Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease.

 Compliance with Written or Telephone Authority Required procedures
C5940 P5940

Recurrent moderate to severe genital herpes

Suppressive therapy

Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5940
C5960 P5960

Initial moderate to severe genital herpes

Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5960
C5961 P5961

Recurrent moderate to severe genital herpes

Episodic treatment

Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

 Compliance with Authority Required procedures - Streamlined Authority Code 5961
C5962 P5962

Herpes zoster

The treatment must be administered within 72 hours of the onset of the rash.

 Compliance with Authority Required procedures - Streamlined Authority Code 5962
C5968 P5968 Herpes zoster ophthalmicus Compliance with Authority Required procedures - Streamlined Authority Code 5968
C5975

Where the patient is receiving treatment at/from a public hospital

Cytomegalovirus infection and disease

Prophylaxis

Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5975

  1. After Schedule 4, Part 2

    insert:

Part 3—General statement for drugs for the treatment of hepatitis C

1  Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

  1. the patient is 18 years or older; and

  2. the patient has been assessed in accordance with paragraph 2 of this Part; and

  3. the patient is:

    a.treated by a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection and is:

    i.a gastroenterologist; or

    ii.a hepatologist; or

    iii.an infectious diseases physician; or

    b.treated in consultation with a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection and who is:

    i.a gastroenterologist; or

    ii.a hepatologist; or

    iii.an infectious diseases physician

2  Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

  1. documented the following information in the patient’s medical records:

    a.evidence of chronic hepatitis C infection; and

    b.evidence of the patient’s hepatitis C virus genotype; and

  2. chosen a regimen in accordance with paragraph 3 of this Part; and

  3. collected the following information for the purposes of the authority application:

    a.the patient’s hepatitis C virus genotype; and

    b.whether the patient is:

    i. cirrhotic; or

    ii. Non-cirrhotic

  4. In this paragraph, evidence of chronic hepatitis C infection is documentation of:

    a.repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

    b.test result showing hepatitis C virus ribonucleic acid (RNA) positive

3  Treatment regimen

For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

  1. is a kind of patient mentioned for an Item in column 2 of the following table; and

  2. is to receive one of the regimens mentioned in column 3 of the same Item of the following table

Item Kind of patient Regimen
1

Patient:

(a)     with Genotype 1; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
2

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
3

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
4

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
5

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
6

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
7

Patient:

(a)     with:

(i)    Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
8

Patient:

(a)     with:

(i)    Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
9

Patient:

(a)     with Genotype 1; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
10

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
11

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
12

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
13

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
14

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
15

Patient:

(a)     with:

(i)    Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
16

Patient:

(a)     with:

(i)    Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)   who is treatment experienced; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.

  1. Schedule 5, after entry for Esomeprazole

    insert:

Olanzapine GRP-15492 Tablet 2.5 mg Oral

APO-Olanzapine

Chem mart Olanzapine

Lanzek

Olanzacor 2.5

Olanzapine AN

Olanzapine RBX

Olanzapine Sandoz

Olanzapine-DRLA

Olanzapine-GA

Ozin 2.5

Terry White Chemists Olanzapine

Zypine

Zyprexa

Tablet 2.5 mg (as benzoate) Oral Olanzapine generichealth 2.5
GRP-15921 Tablet 5 mg Oral

APO-Olanzapine

Chem mart Olanzapine

Lanzek

Olanzacor 5

Olanzapine AN

Olanzapine GH

Olanzapine RBX

Olanzapine Sandoz

Olanzapine-DRLA

Olanzapine-GA

Ozin 5

Terry White Chemists Olanzapine

Zypine

Zyprexa

Tablet 5 mg (as benzoate) Oral Olanzapine generichealth 5
GRP-15884 Tablet 7.5 mg Oral

APO-Olanzapine

Chem mart Olanzapine

Lanzek

Olanzacor 7.5

Olanzapine AN

Olanzapine GH

Olanzapine RBX

Olanzapine Sandoz

Olanzapine-DRLA

Olanzapine-GA

Ozin 7.5

Terry White Chemists Olanzapine

Zypine

Zyprexa

Tablet 7.5 mg (as benzoate) Oral Olanzapine generichealth 7.5
GRP-15513 Tablet 10 mg Oral

APO-Olanzapine

Chem mart Olanzapine

Lanzek

Olanzacor 10

Olanzapine AN

Olanzapine GH

Olanzapine RBX

Olanzapine Sandoz

Olanzapine-DRLA

Olanzapine-GA

Ozin 10

Terry White Chemists Olanzapine

Zypine

Zyprexa

Tablet 10 mg (as benzoate) Oral Olanzapine generichealth 10

  1. Schedule 5, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

    omit from the column headed “Brand”:

    Sumatab

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