PBAC Public Summary Documents - November 2016

Page last updated: 2 March 2018

Public Summary Documents relating to the November 2016 PBAC meeting.

• Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine, 2. Amino acid formula with fat, carbohydrate without phenylalanine, 3. Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid (PKU Easy): 1. Bottles containing oral powder 34 g, 2. Tablet: modified release, 70.8 g protein per 100 g, 3. Oral liquid 130 mL; "1. PKU Easy® Shake & Go, 2. PKU Easy® Microtabs, 3. PKU Easy®
• Adalimumab: Injection 40 mg in 0.8 mL pre-filled pen, Injection 40 mg in 0.8 mL pre-filled syringe; Humira®
• Apomorphine: Injection containing apomorphine (as hydrochloride) 100 mg in 20 mL; Apomine®
• Apremilast: Tablet 30 mg, Pack containing 4 tablets 10 mg, 4 tablets 20 mg and 19 tablets 30 mg; Otezla®
• Blinatumomab: Injection 38.5 microgram [1 vial] and inert substance solution [10 mL vial]; Blincyto®
• Brentuximab vedotin (post-ASCT): Powder for I.V. infusion 50 mg; Adcetris®
• Brentuximab vedotin (ASCT naïve): Powder for I.V. infusion 50 mg; Adcetris®
• Calcipotriol with betamethasone: Foam containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g; Enstilar®
• Carbohydrate formula with minerals: Sachet containing oral powder 21 g, Sachet containing oral powder 31 g, Sachet containing oral powder 42 g, Sachet containing oral powder 52 g; SOS10®, SOS15®, SOS20®, SOS25®
• Carfilzomib: Powder for I.V. infusion 30 m, Powder for I.V. infusion 60 mg; Kyprolis®
• Ceritinib: Capsule 150 mg; Zykadia®
• Cetuximab: Injection 100 mg in 20 mL, Injection 500 mg in 100 mL; Erbitux®
• Daclizumab: Injection 150 mg in 1 mL pre-filled syringe injection 150 mg in 1 mL pre-filled injection device; Zinbryta®
• Epoprostenol: Injection 500 microgram, Injection 1.5 mg; Flolan®
• Eribulin: Solution for I.V. injection containing eribulin mesilate 1 mg in 2 mL; Halaven®
• Fluticasone with salmeterol: Powder for oral inhalation containing fluticasone propionate 500 micrograms with salmeterol (as xinafoate) 50 micrograms per dose; Airflusal Forspiro 500/50
• Fosaprepitant: Powder for I.V. infusion 150 mg; Emend® IV
• Glycomacropeptide and essential amino acids with vitamins and minerals: Sachet containing oral powder 35 g; PKU Restore®
• Glycomacropeptide and essential amino acids: Sachets containing oral powder 20 g; PKU Sphere®
• Gondadotrophin: Powder for injection, 600 I.U, Powder for injection, 1200 I.U; Menopur®
• Goserelin: Implant, 3.6 mg, Implant 10.8 mg; Zoladex® Implant
• High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate: Oral semi-solid 100 g; Keyo®
• Ibrutinib (CLL/SLL): 140 mg capsules, 90; Imbruvica®
• Ibrutinib (MCL): Capsule 140 mg; Imbruvica®
• Icatibant: Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe; Firazyr®
• Infliximab (biosimilar) : Powder for I.V. infusion 100 mg; Renflexis®
• Irinotecan (nanoliposomal): Injection concentrate for I.V. infusion 43 mg (as sucrosofate) in 10 mL; Onivyde®
• Ivacaftor: Sachet containing granules 50 mg, Sachet containing granules 75 mg; Kalydeco®
• Lanreotide: 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®
• Levodopa with carbidopa: Intestinal gel containing levodopa 20 mg with carbidopa (as monohydrate) 5 mg in 1 mL; Duodopa®
• Lumacaftor with ivacaftor: Tablet containing lumacaftor 200 mg with ivacaftor 125 mg; Orkambi®
• Nadroparin: Injection containing nadroparin calcium, (1,900 I.U. anti-Xa) in 0.2 m, (2,850 I.U. anti-Xa) in 0.3 mL, (3800 IU anti-Xa) in 0.4 mL , (5700 IU anti-Xa) in 0.6 mL , (7600 IU anti-Xa) in 0.8 mL , (9500 IU anti-Xa) in 1 mL , (11400 IU anti-Xa) in 0.6 mL, (15200 IU anti-Xa) in 0.8 mL, (19000 IU anti-Xa) in 1 mL - prefilled syringe; Fraxiparine® and Fraxiparine Forte®
• Netupitant with palonosetron: Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride); Akynzeo®
• Nintedanib: Capsule 100 mg, Capsule 150 mg; Ofev®
• Nivolumab (non-squamous NSCLC): Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. infusion 100 mg in 10 mL; Opdivo®
• Nivolumab (squamous NSCLC): Injection concentrate for I.V. infusion 40 mg in 4 mL , Injection concentrate for I.V. infusion 100 mg in 10 mL; Opdivo®
• Nivolumab (RCC): Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. infusion 100 mg in 10 mL; Opdivo®
• Olaparib: Capsule 50mg; Lynparza®
• Omalizumab: Injection 150 mg in 1 mL; Xolair®
• Obinutuzumab: Solution for I.V. infusion 1000 mg in 40 mL; Gazyva®
• Oxycodone with naloxone: Tablet (controlled release) containing oxycodone (as hydrochloride) 80 mg with naloxone (as hydrochloride) 40 mg, Tablet (controlled release) containing oxycodone (as hydrochloride) 60 mg with naloxone (as hydrochloride) 30 mg; Targin®
• Paliperidone: I.M. injection (modified release) 175 mg (as palmitate) in pre-filled syringe, I.M. injection (modified release) 263 mg (as palmitate) in pre-filled syringe, I.M. injection (modified release) 350 mg (as palmitate) in pre-filled syringe, I.M. injection (modified release) 525 mg (as palmitate) in pre-filled syringe; Invega® Trinza™
• Paritaprevir with ritonavir with ombitasvir: Tablet containing 75 mg paritaprevir with 50 mg ritonavir with 12.5 mg ombitasvir; Technivie®
• Pegvisomant: Powder for injection 10 mg, Powder for injection 15 mg, Powder for injection 20 mg; Somavert®
• Pembrolizumab (NSCLC): Powder for injection 50 mg; Keytruda®
• Pembrolizumab (melanoma): Powder for injection 50 mg; Keytruda®
• Pembrolizumab (additional strength): Solution for infusion 100 mg; Keytruda®
• Pirfenidone : Capsule 267 mg; Esbriet®
• Romidepsin: Powder for I.V. infusion 10 mg; Istodax®
• Salbutamol: Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units; Ventolin Nebules®
• Sofosbuvir with velpatasvir: Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir; Epclusa®
• Somatropin: All forms and strengths
• Somatropin: Injection - 6 mg (18 i.u.) in 1.03 mL, 12 mg (36 i.u.) in 1.5 mL, 20 mg (60 i.u.) in 2.5 mL - cartridge (with preservative); Saizen®
• Tenofovir alafenamide, emtricitabine and rilpivirine fixed dose combination tablet containing tenofovir alafenamide 25 mg, emtricitabine 200 mg and rilpivirine 25 mg, Odefsey®
• Tenofovir alafenamide/emtricitabine tablet, tenofovir alafenamide 10 or 25mg and emtricitabine 200mg, Descovy®
• Teriflunomide: Tablet 14 mg; Aubagio®
• Tiotropium with olodaterol: Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses; Spiolto® 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® 
• Triglycerides medium chain formula: Oral liquid solution, 500mL; Nutrini Peptisorb® Energy
• Varenicline: Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack, Tablet 1 mg (as tartrate); Champix®
• Vismodegib: Capsule 150 mg; Erivedge®
• Vitamins, minerals, and trace elements with carbohydrate: Sachets containing oral powder 6 g, 30; Fruitivits®
• Vorinostat: Capsule 100 mg; Zolinza®
• Warfarin: Tablet containing warfarin sodium, 1 mg, Tablet containing warfarin, sodium, 2 mg, Tablet containing warfarin sodium, 5 mg; Warfarin APOTEX®