Source: https://www.global-regulation.com/law/australia/223319/national-health-%2528listing-of-pharmaceutical-benefits%2529-amendment-instrument-2014-%2528no.-11%2529-%2528pb-82-of-2014%2529.html
Timestamp: 2018-12-12 01:57:13
Document Index: 484614838

Matched Legal Cases: ['art 1', '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. 11) (PB 82 of 2014) (Australia)
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 11) (PB 82 of 2014)
Link to law: https://www.comlaw.gov.au/Details/F2014L01395
PB 82 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 11).
(2) This Instrument may also be cited as PB 82 of 2014.
This Instrument commences on 1 November 2014.
[1] Schedule 1, entry for Abiraterone
omit from the column headed “Circumstances”: C4245 substitute: C4654
[2] Schedule 1, after entry for Amino acid formula without phenylalanine in the form Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix)
Sachets containing oral powder 6 g, 30 (MSUD amino5)
MSUD amino5
[3] Schedule 1, entry for Amlodipine with Atorvastatin
Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)
APO-Amlodipine/ Atorvastatin 5/10
C2449 C2450 C2451
Blooms the Chemist Amlodipine/ Atorvastatin 5/10
Cadatin 5/10
Cadivast 5/10
Chem mart Amlodipine/ Atorvastatin 5/10
Terry White Chemists Amlodipine/ Atorvastatin 5/10
Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)
APO-Amlodipine/ Atorvastatin 5/20
Blooms the Chemist Amlodipine/ Atorvastatin 5/20
Cadatin 5/20
Cadivast 5/20
Chem mart Amlodipine/ Atorvastatin 5/20
Terry White Chemists Amlodipine/ Atorvastatin 5/20
Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)
APO-Amlodipine/ Atorvastatin 5/40
Blooms the Chemist Amlodipine/ Atorvastatin 5/40
Cadatin 5/40
Cadivast 5/40
Chem mart Amlodipine/ Atorvastatin 5/40
Terry White Chemists Amlodipine/ Atorvastatin 5/40
Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
APO-Amlodipine/ Atorvastatin 5/80
Blooms the Chemist Amlodipine/ Atorvastatin 5/80
Cadatin 5/80
Cadivast 5/80
Chem mart Amlodipine/ Atorvastatin 5/80
Terry White Chemists Amlodipine/ Atorvastatin 5/80
Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)
APO-Amlodipine/ Atorvastatin 10/10
Blooms the Chemist Amlodipine/ Atorvastatin 10/10
Cadatin 10/10
Cadivast 10/10
Chem mart Amlodipine/ Atorvastatin 10/10
Terry White Chemists Amlodipine/ Atorvastatin 10/10
Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)
APO-Amlodipine/ Atorvastatin 10/20
Blooms the Chemist Amlodipine/ Atorvastatin 10/20
Cadatin 10/20
Cadivast 10/20
Chem mart Amlodipine/ Atorvastatin 10/20
Terry White Chemists Amlodipine/ Atorvastatin 10/20
Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)
APO-Amlodipine/ Atorvastatin 10/40
Blooms the Chemist Amlodipine/ Atorvastatin 10/40
Cadatin 10/40
Cadivast 10/40
Chem mart Amlodipine/ Atorvastatin 10/40
Terry White Chemists Amlodipine/ Atorvastatin 10/40
Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
APO-Amlodipine/ Atorvastatin 10/80
Blooms the Chemist Amlodipine/ Atorvastatin 10/80
Cadatin 10/80
Cadivast 10/80
Chem mart Amlodipine/ Atorvastatin 10/80
Terry White Chemists Amlodipine/ Atorvastatin 10/80
[4] Schedule 1, entry for Azathioprine in the form Tablet 50 mg
omit from the column headed “Brand”: Imazam substitute: Imazan
[5] Schedule 1, entry for Baclofen in the form Tablet 10 mg
Chem mart Baclofen
Terry White Chemists Baclofen
[6] Schedule 1, entry for Baclofen in the form Tablet 25 mg
[7] Schedule 1, entry for Cabazitaxel
omit from the column headed “Circumstances”: C4237 C4262 substitute: C4661 C4662
[8] Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL
[9] Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
Chem mart Cefaclor
Terry White Chemists Cefaclor
(d) omit:
[10] Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
[11] Schedule 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide)
[12] Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100;
Number of Repeats: 0]
Diclofenac AN
C1036 C1054 C3645 C3646
C1036 C1054
[13] Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100;
Number of Repeats: 3]
P1036 P1054 P3645
[14] Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50;
[15] Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50;
[16] Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg
Chem mart Diltiazem
GenRx Diltiazem
Terry White Chemists Diltiazem
[17] Schedule 1, entry for Docetaxel in each of the forms: Solution concentrate for I.V. infusion 140 mg in 7 mL; and Solution concentrate for I.V. infusion 160 mg in 16 mL
omit from the column headed “Circumstances”: C3888 C3892 C3916 C3956 C4078 C4140 C4160 C4239
[18] Schedule 1, entry for Docetaxel in each of the forms: Powder for I.V. infusion 20 mg with solvent; and Powder for I.V. infusion 80 mg
omit from the column headed “Circumstances”: C4078 C4140 C4160 C4239
[19] Schedule 1, entry for Docetaxel in each of the forms: Solution concentrate for I.V. infusion 20 mg in 1 mL; Solution concentrate for I.V. infusion 20 mg in 2 mL; Solution concentrate for I.V. infusion 80 mg in 4 mL; and Solution concentrate for I.V. infusion 80 mg in 8 mL
omit from the column headed “Circumstances” (all instances): C3888 C3892 C3916 C3956 C4078 C4140 C4160 C4239
[20] Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 5 mg
Aridon APN 5
C4219 C4220 C4224
[21] Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg
Aridon APN 10
[22] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial
[23] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
[24] Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg
[25] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
Pharmorubicin Solution
[26] Schedule 1, entry for Fluconazole in each of the forms: Solution for I.V. infusion 100 mg in 50 mL; and Solution for I.V. infusion 200 mg
C3613 C3614 C3615 C3616 C3617 C3618
[27] Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Contour)
Test strips, 100 (Contour next)
[28] Schedule 1, after entry for Indacaterol in the form Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler)
C4655
[29] Schedule 1, entry for Indapamide
APO-Indapamide SR
Chem mart Indapamide SR
Terry White Chemists Indapamide SR
[30] Schedule 1, entry for Interferon Beta-1b
C1175 C1751
[31] Schedule 1, entry for Ipratropium in each of the forms: Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30; and Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30
C1754 C1755
[32] Schedule 1, entry for Irbesartan in the form Tablet 75 mg
Irbesartan Actavis 75
[33] Schedule 1, entry for Irbesartan in the form Tablet 300 mg
Irbesartan Actavis 300
[34] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL
[35] Schedule 1, entry for Lactulose
GenRx Lactulose
[36] Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g
Diaformin XR 1000
[37] Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial
[38] Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
Metoclopramide AN
MP NP MW PDP
[39] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
Metoprolol AN
[40] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
[41] Schedule 1, entry for Mometasone in the form Cream containing mometasone furoate 1 mg per g, 15 g
Momasone
[42] Schedule 1, entry for Norethisterone with Ethinyloestradiol
Pack containing 12 tablets 500 micrograms‑35 micrograms, 9 tablets 1 mg‑35 micrograms and 7 inert tablets
Improvil 28 Day
[43] Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg
in 50 mL
omit from the column headed “Circumstances” (all instances): C3186 C3890 C3902 C3917 C3955 C3956
[44] Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound
insert in numerical order in the column headed “Circumstances”: C4657
[45] Schedule 1, after entry for Penicillamine in the form Tablet 250 mg
Tablet 2 mg (as hemisesquihydrate)
C4656
Tablet 4 mg (as hemisesquihydrate)
C4658
Tablet 6 mg (as hemisesquihydrate)
Tablet 8 mg (as hemisesquihydrate)
Tablet 10 mg (as hemisesquihydrate)
Tablet 12 mg (as hemisesquihydrate)
[46] Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
Perindopril Combi Actavis 4/1.25
[47] Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
[48] Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
[49] Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity: 10; Number of Repeats: 0]
[50] Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity: 10; Number of Repeats: 1]
[51] Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 5; Number of Repeats: 0]
[52] Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 5; Number of Repeats: 1]
[53] Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
C1211 C1241 C1975
[54] Schedule 1, entry for Triglycerides―medium chain, formula in each of the forms: Oral powder 400 g (Lipistart); and Oral powder 400 g (Monogen)
omit from the column headed “Circumstances”: C1068 C1511 C1513 C1670 C1671
substitute: C4651 C4652 C4653 C4659 C4660
[55] Schedule 1, after entry for Triglycerides―medium chain, formula in the form Oral powder 400 g (Monogen)
Oral powder 400 g (Peptamen Junior)
[56] Schedule 1, after entry for Vitamins, minerals and trace elements with carbohydrate in the form Oral powder 200 g (Paediatric Seravit)
Sachets containing oral powder 6 g, 30 (FruitiVits)
[57] Schedule 1, entry for Zolmitriptan
APO-Zolmitriptan
C4573
[58] Schedule 3, after details relevant to Responsible Person code IA
[59] Schedule 4, Part 1, entry for Abiraterone
C4654
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with chemotherapy; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone
[60] Schedule 4, Part 1, entry for Cabazitaxel
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
The treatment must not be used in combination with abiraterone; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel
Compliance with Authority Required procedures - Streamlined Authority Code 4662
[61] Schedule 4, Part 1, omit entry for Docetaxel
[62] Schedule 4, Part 1, after entry for Indacaterol
Patient must have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist.
Compliance with Authority Required procedures - Streamlined Authority Code 4655
[63] Schedule 4, Part 1, omit entry for Paclitaxel
[64] Schedule 4, Part 1, entry for Paclitaxel, nanoparticle albumin-bound
C4657
Stage IV (metastatic) adenocarcinoma of the pancreas
The treatment must be in combination with gemcitabine; AND
The condition must not have been treated previously with PBS-subsidised therapy; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures - Streamlined Authority Code 4657
[65] Schedule 4, Part 1, after entry for Pemetrexed
Intractable partial epileptic seizures
The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents
Must be treated by a neurologist
Compliance with Authority Required procedures - Streamlined Authority Code 4656
Patient must have previously been issued with an authority prescription for this drug
Compliance with Authority Required procedures - Streamlined Authority Code 4658
[66] Schedule 4, Part 1, omit entry for Polyethylene glycol 400
[67] Schedule 4, Part 1, entry for Triglycerides―medium chain, formula
C4652
C4653
C4659
Dietary management of conditions requiring a source of medium chain triglycerides
Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders
[68] Schedule 4, Part 1, entry for Vitamins, minerals and trace elements with carbohydrate
Dietary management of conditions requiring a highly restrictive therapeutic diet
Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations
Patient must be aged 3 years or older