What’s New

August 2019

New Product Summaries
  • Aciclovir Apotex
  • Amiloxyn
  • Arnuity Ellipta
  • Azithromycin-AFT
  • Calitrol
  • Estrogel
  • Fenocol
  • Fenofibrate Cipla
  • Fleurstat BVgel
  • Flucloxacillin [Athlone]
  • Flucloxacillin [Medreich]
  • Gilmat
  • Hydromorphone Juno
  • Hydromorphone Juno-HP
  • MycoCept
  • Noumed Rosuvastatin
  • Ogivri
  • Ostelin Infant Vitamin D3
  • Ralovista
  • Rixalt
  • Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan
Content Updates to Monographs
As part of our rigorous editorial updating process, the AusDI editorial team monitors safety information issued by the Australian Therapeutic Goods Administration (TGA), the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA), the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). FDA-approved indications and dosing information in adults and children are also reviewed by our editorial team and included in selected monographs.

The Deferiprone (Systemic) monograph has updated safety information regarding use in children. Neurological disorders have previously been reported in children treated for several years with three times the maximum recommended deferiprone dose. However, more recently, hypotonia, instability, inability to walk, and hypertonia with inability of limb movement have been reported in children using recommended doses of deferiprone during postmarketing evaluation.

New Consumer Medicine Information (CMI)
  • Amiloxyn
  • BTC Lercanidipine
  • Calitrol
  • Estrogel
  • Lercanidipine Apotex
  • MycoCept
  • Ralovista
  • Raloxifene GH
  • Rixalt
  • Temozolomide Juno
  • Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan
New Product Information (PI)
  • Estrogel
  • Optive Lubricant
  • Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan

Product information with safety updates includes Aclasta, Aeron, Alendronate Plus D3 Sandoz, Alphamox, Apo-Montelukast, Apo-Mycophenolate Capsules, Apo-Mycophenolate Tablets, Apo-Telmisartan HCTZ, Aranesp, Aripiprazole Sandoz, Ativan, Azactam, Azith, Baraclude, Bimatoprost Sandoz, Cerdelga, Clonac, Clozaril, Cordarone X, Coversyl, Coversyl Plus, Cyproterone Sandoz 100mg, DBL Cefotaxime, DBL Cephalothin, DBL Irinotecan, DBL Methotrexate, DBL Pethidine, Denpax, DermAid Cream, Dithiazide, Doryx, Duloxetine Sandoz, Durotram XR, Endep, Epclusa, Ezetimibe/Simvastatin Sandoz, Genotropin, Haldol, Harvoni, Herceptin, Herceptin SC, Idaprex Combi, Intuniv, Invanz, Kadcyla, Kaletra, Keytruda, Kiovig, Levemir, Luvox, Lynparza Capsules, MabCampath, Maxor, Mayne Pharma Doxycycline, Methotrexate Ebewe, Mirtazapine Sandoz, Mirtazapine Sandoz ODT, Neo-Mercazole, Osteovan, Pariet, Pariet 10, Perindo, Phenobarb, PiperTaz Sandoz, Plasma-Lyte 148, Plasma-Lyte 56 and 5% Glucose, Prexum, Prexum Combi, Primaxin, Revlimid, Rixadone, Simvastatin Sandoz, Sovaldi, Symmetrel, Tacrolimus Sandoz, Taltz, Tasigna, Tazocin EF, Teveten Plus, Tivicay, Tracleer, Trelegy Ellipta, Voriconazole Sandoz, Vosevi, Vpriv, Zeldox, Zerbaxa, Zimstat, Zithromax, Zithromax IV, Zoton, and Zyrtec.

Product information with an update to indications includes Cabometyx, Dupixent, Giotrif, Influvac Tetra, Kalydeco, Lynparza Tablets, and Orkambi.

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