4 May 2016 - Throughout the year the TGA will be publishing information relating to new or extended uses of registered prescription medicines on its website.
Changes commonly include 'new uses' and 'extended uses'. A new use is where an existing medicine is approved for an additional therapeutic use. An extended use is where an exisiting medicine is approved to treat a broader range of patients, e.g. wider age range.These types of changes are called 'extension of indications'.
The decision to approve an 'extension of indications' for a registered prescription medicine follows a comprehensive review by TGA scientists and clinicians on the safety and efficacy of the proposed new or extended use.
The trade name, sponsor and active ingredient for each medicine reflects the information entered into the ARTG when the new or extended use was first approved. This webpage provides a summary of the new or extended indication and does not include all indications.
For more details, go to: http://www.tga.gov.au/prescription-medicines-new-or-extended-uses-registered-medicines-0