PBAC Public Summary Documents - July 2014

Page last updated: 5 June 2015

Public Summary Documents relating to the July 2014 PBAC meeting.

• Abiraterone Acetate, tablet, 250 mg, Zytiga®, Janssen-Cilag Pty Ltd
• Adalimumab, 40 mg/0.8 mL injection, 2 x 0.8 mL cartridges and 2 x 0.8 mL syringes, 40 mg/0.8 mL injection, 6 x 0.8 mL cartridges and 6 x 0.8 mL syringes, Humira®
• Alemtuzumab, solution for infusion, 10 mg/ mL, Lemtrada®
• Amino Acid Formula with Vitamins and Minerals without Valine, oral liquid: powder for, 30 x 6 g sachets, MSUD amino5®
• Amino Acid Formula with Vitamins and Minerals without Phenylalanine oral liquid, 30 x 125 mL cans, PKU Lophlex LQ 20®
• Aripiprazole, 300 mg injection: modified release [1 x 300 mg vial] (&) inert substance diluent [2 x 3 mL syringe], 400 mg injection: modified release [1 x 400 mg vial] (&) inert substance diluent [2 x 3 mL syringe], Abilify Maintena®
• Brentuximab Vedotin, injection, 50 mg, Adcetris®
• Collagenase Clostridium Histolyticum, 900 microgram injection [1 x 900 microgram vial] (&) inert substance [1 x 3 mL vial], Xiaflex®
• Dapagliflozin, 10 mg tablet, Forxiga®, AstraZeneca Pty Ltd
• Dapagliflozin and Metformin XR (FDC), modified release tablets, 10 mg/500 mg, 10 mg/1000 mg, 5 mg/1000 mg, Xigduo XR®
• Dasatinib, tablets, 20 mg, 50 mg, 70 mg and 100 mg, Sprycel®, Bristol Myers Squibb Australia Pty Ltd
• Empagliflozin, oral tablet, 10 mg, 25 mg, Jardiance®
• Enzalutamide, capsule, 40 mg, Xtandi®
• Epoprostenol, 500 microgram injection, vial; Epoprostenol 1.5 mg injection, vial; Veletri®
• Escitalopram, 20 mg/mL oral liquid, 15 mL, Lexapro®
• Etanercept injection 50 mg in 1 mL single use auto-injector, Etanercept injection 50 mg in 1 mL single use pre-filled syringes, Enbrel®
• Ezetimibe and Rosuvastatin tablets, ezetimibe 10mg + rosuvastatin 5mg; ezetimibe 10mg + rosuvastatin 10mg; ezetimibe 10mg + rosuvastatin 20mg; ezetimibe 10mg + rosuvastatin 40mg, Rosuzet®
• Fluticasone Furoate and Vilanterol Trifenatate, dry powder inhaler, fluticasone furoate 100 microgram/actuation + vilanterol (as trifenatate) 25 microgram/actuation, Breo® Ellipta®
• Glucose Indicator Blood Strip: diagnostic, 50, Medissentials Diabetic Test Strips®
• Golimumab, 50 mg/0.5 mL injection, 1x 0.5 mL, syringe Simponi®;Infliximab, 100 mg injection, 1x 100 mg vial, Remicade®; Ustekinumab 45 mg/0.5 ml injection, 1x 0.5 ml vial, Stelara®; Janssen-Cilag Pty Ltd
• Glycine with Carbohydrate containing 500 mg L-glycine oral liquid: powder for, 30 x 4 g sachets, Glycine500®
• Incobotulinumtoxin A, powder for solution for injection, 100LD50 units, Xeomin®
• Indacaterol with Glycopyrronium (FDC), indacaterol 110 microgram + glycopyrronium 50 microgram, inhalation: powder for, 30 capsules, Ultibro® Breezhaler® 110/50
• Infliximab, injection vial, 100 mg, Remicade®
• Ingenol Mebutate, gel 0.15 mg/g (0.015%), 3 x 0.47 g, Picato®
• Lisdexamdefamine Dimesilate, capsules, 30 mg, 50 mg & 70 mg, Vyvanse®
• Lixisenatide,10 microgram/0.2 mL injection, 14 unit doses (&) 20 microgram/0.2 mL injection, 14 unit doses, Lyxumia® treatment initiation pack; (with insulin) Lyxumia®, Sanofi-Aventis Australia Pty Ltd
• Lixisenatide,10 micrograms/0.2 ml injection, 14 unit doses (&) 20 micrograms/0.2 ml injection, 14 unit doses, Lyxumia® Treatment Initiation Pack; (for dual and triple therapy), Lyxumia®, Sanofi-Aventis Australia Pty Ltd
• Mifepristone with Misoprostol, mifepristone 200mg tablet [1 tablet] (&) misoprostol 200 microgram tablet [4 tablets], 1 pack, MS-2 step®
• Multicomponent Meningococcal Group B Vaccine (4CMenB), injection, 0.5mL, Bexsero®
• Obinutuzumab, solution for IV infusion, 1000 mg/40 mL, Gazyva®, Roche Products Pty Ltd
• Olodaterol, 2.5 microgram/actuation inhalation: solution for, 60 actuations, Striverdi® Respimat® Boehringer Ingelheim Pty Ltd
• Panitumumab, injection, 100 mg/5 mL and 400 mg/20 mL, Vectibix®
• Perampanel, tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, Fycompa®
• Pomalidomide,capsules, 3 mg and 4 mg, Pomalyst®, Celgene Pty Ltd
• Ranibizumab, 2.3 mg/0.23 mL injection, 0.23 mL vial, Lucentis® (DME)
• Ranibizumab, 2.3 mg/0.23 mL injection, 0.23 mL vial, Lucentis® (RVO)
• Regorafenib, tablet, 40 mg, Stivarga®, Bayer Australia Limited
• Rituximab. solution for IV infusion, 100 mg in 10 mL, 500 mg in 50 mL, Mabthera®
• Ruxolitinib, 5mg, 15mg, 20mg tablets, Jakavi®, Novartis Pharmaceuticals Australia Pty Ltd
• Simeprevir, 150 mg capsule, Olysio®
• Sofosbuvir, 400mg tablet, Sovaldi®, Gilead Sciences Pty Ltd
• Sorafenib, 200mg tablet,Nexavar®, Bayer Australia Ltd
• Strontium Ranelate, 2g granules, 28x2 sachets, Protos®
• Testosterone - Review of proposed amendments to PBS restrictions for Testosterone products
• Thiazolidinediones, glucagon-like peptide-1, and sodium-glucose co-transporter 2 inhibitors
• Triglycerides Long Chain with Glucose Polymer, triglycerides long chain with glucose polymer oral liquid, 27 x 200 mL cartons, Sno-Pro®
• Triglycerides Medium Chain Formula, triglycerides medium chain formula oral liquid, powder for, 400 g, Peptamen Junior®
• Trivalent Influenza Vaccine
• Umeclidinium (as Bromide), 62.5 microgram/actuation, inhalation: powder for, 30 actuations, Incruse® Ellipta®
• Umeclidinium Bromide with Vilanterol Trifenatate, umeclidinium (as bromide) 62.5 microgram/actuation + vilanterol (as trifenatate) 25 microgram/actuation inhalation: powder for, 30 actuations, Anoro® Ellipta®
• Vedolizumab, injection, 1 x 300 mg vial, Entyvio®, Takeda Pharmaceuticals Australia Pty Ltd
• Vitamins, Minerals and Trace Elements with Carbohydrate, vitamins, minerals and trace elements with carbohydrate oral liquid: powder for, 30 X 6 g sachets FruitiVits ®
• Vortioxetine,tablets, 5 mg, 10 mg, 15 mg and 20 mg, Brintellix®, Lundbeck Australia Pty Ltd