Source: https://www.legislation.gov.au/Details/F2014L00147
Timestamp: 2019-11-20 04:49:44
Document Index: 641828785

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 2)
Details: F2014L00147
- F2014L00147
PB 9 of 2014 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (No. PB 71 of 2012) to provide for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities, section 100 only status and prescriber bag only status.
Registered 17 Feb 2014
Tabled HR 24-Feb-2014
Tabled Senate 03-Mar-2014
Date of repeal 02 Mar 2014
PB 9 of 2014
Dated 12th February 2014
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 2).
(2) This Instrument may also be cited as PB 9 of 2014.
[1] Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine
Oral powder 400 g (Phenex‑2)
[2] Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
[3] 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]
Clavam 875 mg/125 mg
[4] 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]
[5] Schedule 1, entry for Anastrozole in the form Tablet 1 mg
Azastrole
[6] Schedule 1, after entry for Aprepitant
Sachets of oral powder 4 g containing 200 mg arachidonic acid and 100 mg docosahexaenoic acid , 30 (keyomega)
keyomega
[7] Schedule 1, entry for Bicalutamide in the form Tablet 50 mg
[8] Schedule 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL
[9] Schedule 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements
omit from the column headed “Circumstances”: C1276 substitute: C4438
[10] Schedule 1, after entry for Carbohydrate, fat, vitamins, minerals and trace elements
Sachets containing oral powder 21.5 g, 30 (basecal 100)
basecal 100
Sachets containing oral powder 43 g, 30 (basecal 200)
basecal 200
[11] Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 150 mg in 15 mL
[12] Schedule 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL
[13] Schedule 1, entry for Dicloxacillin in the form Capsule 500 mg (as sodium)
[14] Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent
omit from the column headed “Responsible Person”: YA substitute: AF
[15] Schedule 1, after entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
Sachets of oral powder 4 g containing 200 mg docosahexaenoic acid, 30 (docomega)
docomega
[16] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
[17] Schedule 1, entry for Felodipine in each of the forms: Tablet 2.5 mg (extended release); Tablet 5 mg (extended release); and
omit from the column headed “Responsible Person” for the brand “Plendil ER”: AP substitute: GX
[18] Schedule 1, entry for Fludarabine in the form Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL
AS-Fludarabine
[19] Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; and Capsule 400 mg
[20] Schedule 1, entry for Gabapentin in the form Tablet 800 mg
[21] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
[22] Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL
Gemcitabine-AS
[23] Schedule 1, entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL
[24] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)
[25] Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12
[26] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
[27] Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL
[28] Schedule 1, after entry for Linagliptin
Linagliptin with metformin
Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride
C4423 C4448
Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride
Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride
[29] Schedule 1, entry for Lisinopril in the form Tablet 5 mg
Auro‑Lisinopril 5
[30] Schedule 1, entry for Lisinopril in the form Tablet 10 mg
Auro-Lisinopril 10
[31] Schedule 1, entry for Lisinopril in the form Tablet 20 mg
Auro-Lisinopril 20
[32] Schedule 1, entry for Mitozantrone in the form Injection 20 mg (as hydrochloride) in 10 mL
[33] Schedule 1, entry for Nevirapine in the form Tablet 200 mg
Nevipin
[34] Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg
[35] Schedule 1, entry for Olanzapine in the form Tablet 5 mg
[36] Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg
[37] Schedule 1, entry for Olanzapine in the form Tablet 10 mg
[38] Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)
[39] Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)
[40] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL
[41] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
[42] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL
[43] Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
[44] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
[45] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
[46] Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
(a) insert in numerical order in the column headed “Circumstances”: C4435 C4439 C4444
(b) insert in numerical order in the column headed “Purposes”: P4439
[47] Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 2]
(b) insert in numerical order in the column headed “Purposes”: P4444
[48] Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 5]
(b) insert in numerical order in the column headed “Purposes”: P4435
[49] Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
[50] Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]
[51] Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]
[52] Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg
Quinapril Pfizer
[53] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]
Rispernia
[54] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]
[55] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]
[56] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]
[57] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]
[58] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]
[59] Schedule 1, entry for Risperidone in the form Tablet 3 mg
[60] Schedule 1, entry for Risperidone in the form Tablet 4 mg
[61] Schedule 1, after entry for Saxagliptin
Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride
C4423 C4451
Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride
Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride
[62] Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
Sertraline‑GA
[63] Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
[64] Schedule 1, entry for Somatropin
Injection 5 mg (15 i.u.) in 1 mL cartridge (with preservative)
[65] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]
[66] Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]
[67] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]
[68] Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]
[69] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]
[70] Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]
[71] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]
[72] Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]
[73] Schedule 1, entry for Temozolomide in the form Capsule 250 mg
[74] Schedule 1, entry for Terbutaline
Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses
[75] Schedule 1, entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Topotecan Agila”: YA substitute: AF
[76] Schedule 1, after entry for Trifluoperazine in the form Tablet 5 mg (as hydrochloride)
Oral liquid 250 mL, 18 (carbzero)
[77] Schedule 1, after entry for Triglycerides, medium chain in the form Oral emulsion 250 mL (Liquigen)
Oral liquid 250 mL, 18 (betaquik)
C4443 C4447
[78] Schedule 3, after details relevant to Responsible Person code NI
Norac Pharma Australia Pty Ltd
22 164 670 008
[79] Schedule 3
[80] Schedule 4, Part 1, after entry for Aprepitant
[81] Schedule 4, Part 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements
Proven inborn errors of protein metabolism
Patient must be unable to meet their energy requirements with permitted food and formulae
[82] Schedule 4, Part 1, after entry for Carbohydrate, fat, vitamins, minerals and trace elements
[83] Schedule 4, Part 1, after entry for Docetaxel
[84] Schedule 4, Part 1, after entry for Linagliptin
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
A patient whose diabetes was previously demonstrated unable to be controlled with metformin 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 4423
C4448
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and linagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4448
[85] Schedule 4, Part 1, entry for Pazopanib
Advanced (unresectable and/or metastatic) soft tissue sarcoma
Patient must have previously been issued with an authority prescription for pazopanib; AND
Applications for continuing therapy may be made by telephone
Patient must require dose adjustment; AND
Patient must have received prior chemotherapy treatment including an anthracycline; AND
Patient must not have received prior treatment with an angiogenesis inhibitor; AND
Patient must not have any of the following conditions:
adipocytic soft tissue sarcoma;
gastrointestinal stromal tumour (GIST);
rhabdomyosarcoma other than alveolar or pleomorphic;
Ewings tumour/primitive neuroectodermal tumour;
dermofibromatosis sarcoma protuberans;
inflammatory myofibroblastic sarcoma;
malignant mesothelioma;
mixed mesodermal tumour of the uterus
The authority application must be made in writing
[86] Schedule 4, Part 1, after entry for Saxagliptin
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and saxagliptin
Compliance with Authority Required procedures - Streamlined Authority Code 4451
[87] Schedule 4, Part 1, after entry for Triamcinolone
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency
Carbzero should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist
[88] Schedule 4, Part 1, entry for Triglycerides, medium chain
Patient must have chylous ascites; OR
Patient must have chylothorax; OR
Patient must have hyperlipoproteinaemia type 1; OR
Patient must have long chain fatty acid oxidation disorders; OR