Medical Device Approval
Medical Device Approval

Juno Pharmaceuticals is pleased to announce the TGA granted approval for the following Medical Device Class 3 application in February 2015:

iAluRil Procedure Pack. iAluRil prefill contains: 800 mg/50 ml sodium hyaluronate (1.6%) and 1 g /50 ml sodium chondroitin sulfate (2%). iAluRil is  indicated to re-establish the glycosaminoglycan layers (GAGs) of the urothelial vesical tissue in cases in which their loss can cause frequent and recurring problems such as Painful Bladder Syndrome (PBS), interstitial cystitis, treatment and prevention of recurrent urinary tract infection, cystitis as a result of Bacillus Calmette ± Guerin therapy, or chemical and radiation therapy. iAluRil is also indicated in the cases where the loss of the glycosaminoglycan layers (GAGs) is associated with forms of chronic inflammation, in which their composition and integrity appears compromised in different ways. iAluRil  Procedure Pack is  presented in a 50ml pre-filled syringe with a Luer-Lock adaptor for easy use.