PBAC Public Summary Documents - November 2017

Page last updated: 9 November 2018

Public Summary Documents relating to the November 2017 PBAC meeting.

• Alirocumab: Injection 75 mg in 1 mL single dose pre-filled pen, Injection 150 mg in 1 mL single dose pre-filled pen; Praluent®
• Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids, without phenylalanine: Oral powder 400 g (PKU Start); PKU Start® - Updated 26 October 2018
• Apremilast: Tablet 30 mg, Pack containing 4 tablets of 10 mg , 4 tablets of 20 mg and 19 tablets of 30 mg; Otezla®
• Arginine: Tablet 500 mg; Arginine Easy®
• Atezolizumab: Solution concentrate for I.V. infusion 1200 mg in 20 mL; Tecentriq®
• Baricitinib: Tablet 2 mg, Tablet 4 mg; Olumiant®
• Bezlotoxumab: Solution concentrate for I.V. infusion 1000 mg in 40 mL; Zinplava®
• Brivaracetam: Tablet 25 mg, Table 50 mg, Tablet 75 mg, Tablet 100 mg, Oral suspension 10 mg per mL, 300 mL; Briviact®
• Budesonide: Capsule (modified release) 3 mg; Entocort®
• Budesonide with eformoterol: Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses, Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 120 doses; DuoResp® Spiromax®
• Canakinumab: Powder for injection 150 mg with solvent, Solution for injection 150 mg in 1 mL; Ilaris®
• Cladribine: Tablet 10 mg; Mavenclad®          
• Crizotinib: Capsule 200 mg, Capsule 250 mg; Xalkori®
• Dapagliflozin, 2. Dapagliflozin with metformin, 3. Dapagliflozin with saxagliptin: 1. Tablet 10 mg (as propanediol monohydrate), 2. Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride, Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride, Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride, 3. Tablet containing 10 mg dapagliflozin (as propanediol monohydrate) with 5 mg saxagliptin; 1. Forziga®, 2. Xigduo® XR, 3. Qtern®
• Daratumumab : Solution concentrate for I.V infusion 100 mg in 5 mL, Solution concentrate for I.V infusion 400 mg in 20 mL; Darzalex®
• Deferiprone: Tablet 1000 mg; Ferriprox®
• Dexamethasone: Intravitreal injection 700 micrograms; Ozurdex®
• Dulaglutide: Injection 1.5 mg in 0.5 mL single dose pre-filled pen; Trulicity®
• Empagliflozin, 2. Empagliflozin with metformin, 3. Linagliptin, 4. Linagliptin with metformin: 1. Tablet 10mg, Tablet 25 mg, 2. Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride, Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride, Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride, Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride, 3. Tablet 5 mg, 4. Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride, Tablet containing 2.5 mg linagliptin with 1 g metformin hydrochloride, Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride; Jardiance®, Jardiamet®, Trajenta®, Trajentamet®
• Empagliflozin with linagliptin: Tablet containing 10 mg empagliflozin with 5 mg linagliptin, Tablet containing 25 mg empagliflozin with 5 mg linagliptin; Glyxambi®
• Evolocumab: Injection 420 mg in 3.5 mL single use pre-filled cartridge, Injection 140 mg in 1 mL single use pre-filled pen; Repatha®
• Follitropin delta: Solution for injection 12 micrograms per 0.36 mL pre-filled cartridge, Solution for injection 36 micrograms per 1.08 mL pre-filled cartridge, Solution for injection 72 micrograms per 2.16 mL pre-filled cartridge; Rekovelle®
• Glecaprevir with pibrentasvir: Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir; Maviret®
• Glycomacropeptide and essential amino acids with vitamins and minerals: Sachets containing oral powder 16 g, 60 (PKU Build 10), Sachets containing oral powder 32g, 30 (PKU Build 20); PKU Build 10®, PKU Build 20®
• Glycomacropeptide and essential amino acids with vitamins and minerals: Bars 81 g, 14; Tylactin Complete®
• Golimumab (nr-axSpA): Injection 50 mg in 0.5 mL single use pre-filled syringe ; Simponi®
• Golimumab (ulcerative colitis): Injection 100 mg in 1 mL single use pre-filled syringe/injection device; Simponi®
• Ibrutinib (CLL/SLL): Capsule 140 mg ; Imbruvica®
• Ibrutinib (MCL): Capsule 140 mg; Imbruvica®
• Infliximab: Powder for I.V. infusion 100 mg; Renflexis®
• Insulin degludec with insulin aspart: Injections, cartridges, 70 units-30 units per mL, 3 mL, 5, Injections, pre-filled pen, 70 units-30 units per mL, 3 mL, 5; Ryzodeg FlexTouch®, Ryzodeg Penfill®
• Insulin lispro: Injections (human analogue), cartridges, 200 units per mL, 3 mL, 5; Humalog® U200 Kwikpen®
• Lanreotide (acromegaly and functional carcinoid tumour): Injection 60 mg (as acetate) in single dose pre-filled syringe, Injection 90 mg (as acetate) in single dose pre-filled syringe, Injection 120 mg (as acetate) in single dose pre-filled syringe; Somatuline® Autogel®
• Lanreotide (GEP-NETs): Injection 120 mg (as acetate) in single dose pre-filled syringe; Somatuline® Autogel® - Updated 26 October 2018
• Lenalidomide: Capsule 5 mg, Capsule 10 mg, Capsule 15 mg, Capsule 25 mg; Revlimid®   
• Lenvatinib: Capsule 10 mg (as mesilate), Capsule 4 mg (as mesilate); Lenvima®
• Medium chain triglycerides, 2. Triglycerides long chain: 1. Oral liquid 225 mL (betaquik), 2. Oral liquid 225 mL (carbzero); 1. Betaquik ®, 2. Carbzero®
• Mepolizumab: Powder for injection 100 mg; Nucala®
• Midostaurin,Capsule 25 mg, Rydapt®
• Migalastat: Capsule containing migalastat hydrochloride 150 mg; Galafold®
• Nivolumab: Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. infusion 100 mg in 10 mL; Opdivo®
• Nusinersen: Solution for injection 12 mg in 5 mL; Spinraza®
• Obinutuzumab: Solution for I.V. infusion 1000 mg in 40 mL; Gazyva®
• Ocrelizumab: Solution concentrate for I.V. infusion 300 mg in 10 mL; Ocrevus®
• Osimertinib: Tablet 40 mg, Tablet 80 mg; Tagrisso®
• Palbociclib: Capsule 75 mg, Capsule 100 mg, Capsule 125 mg; Ibrance®
• Peginterferon alfa-2A: Injection 135 micrograms in 0.5 mL single use pre filled syringe, Injection 180 micrograms in 0.5 mL single use pre-filled syringe; Pegasys®
• Pembrolizumab (NSCLC): Powder for injection 50 mg , Solution concentrate for I.V. infusion 100 mg in 4 mL; Keytruda®
• Pembrolizumab (urothelial cancer): Powder for injection 50 mg, Solution concentrate for I.V. infusion 100 mg in 4 mL; Keytruda®
• Pomalidomide: Capsule 3 mg, Capsule 4 mg; Pomalyst®
• Ponatinib: Tablet 15 mg (as hydrochloride), Tablet 45 mg (as hydrochloride); Iclusig® - Updated 9 November 2018
• Pralatrexate: Solution for I.V. infusion 20 mg in 1 mL; Folotyn®
• Radium (223Ra): Injection containing radium (223Ra) dichloride 6.6 MBq in 6 mL vial; Xofigo®
• Ribociclib: Tablet 200 mg; Kisqali®
• Sevelamer: Powder for oral liquid 2.4 g (as carbonate); Renvela®
• Sodium phenylbutyrate: Granules for oral suspension 483 mg (as sodium) per g, 174 g; Pheburane®
• Sonedigib: Capsule 200 mg; Odomzo®
• Teduglutide: Powder for injection 5 mg with solvent; Revestive®
• Tetracosactrin: Compound depot injection 1 mg in 1 mL; Synacthen® Depot 1 mg/1 mL
• Tiotropium: Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations); Spiriva® Respimat®
• Trifluridine with tipiracil: Tablet containing 15 mg trifluridine with 6.14 mg tipiracil (as hydrochloride), Tablet containing 20 mg trifluridine with 8.19 mg tipiracil (as hydrochloride); Lonsurf®
• Varenicline: Tablet 1 mg (as tartrate); Champix®
• Vildagliptin, 2. Vildagliptin with metformin: 1. Tablet 50 mg, 2. Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride, Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride, Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride; 1. Galvus®, 2. Galvumet®
• Venetoclax: Tablet 10 mg, Tablet 50 mg, Tablet 100 mg; Venclexta®
• Vismodegib: Capsule 150 mg; Erivedge®