Prescription medicines: new or extended uses, or new combinations of registered medicines
Over time, the approved therapeutic uses of prescription medicines registered on the Australian Register of Therapeutic Goods (ARTG) can change.
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 existing medicine is approved to treat a broader range of patients, e.g. wider age range.These types of changes are called 'extension of indications'. A 'new combination' is where two or more previously registered medicines are combined into a single product.
The decision to approve an 'extension of indications' or 'new combination' for registered prescription medicines follows a comprehensive review by TGA scientists and clinicians on the safety and efficacy of the proposed use of the product.
Throughout the year we will be publishing information relating to new or extended uses of registered prescription medicines on the TGA website.
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 indications. For a full list of registered indications for each product please refer to the Product Information database.
Registration of new or extended uses of registered medicines
Orphan drug 
February 2017
AFLURIA QUAD
Evaluation commenced: 03 January 2017
Registration decision: 01 February 2018
Date registered: 02 February 2018
inactivated quadrivalent influenza vaccine (split virion)
Seqirus Pty Ltd
Afluria Quad is now also indicated for the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine, in persons aged 5-17 years.
RIXADONE
Evaluation commenced: 08 August 2017
Registration decision: 30 January 2018
Date registered: 05 February 2018
risperidone
Alphapharm Pty Ltd
Generic medicine
Rixadone is now also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type.
LEFLUNOMIDE GENERICHEALTH
Evaluation commenced: 27 November 2017
Registration decision: 01 February 2018
Date registered: 06 February 2018
leflunomide
Southern Cross Pharma Pty Ltd
Generic medicine
Leflunomide Generichealth is now also indicated for the treatment of active psoriatic arthritis. Leflunomide Generichealth is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. The combined use of Leflunomide Generichealth with other Disease Modifying Anti-Rheumatic Drugs (DMARDs) has not been adequately studied.
OPDIVO
Evaluation commenced: 31 January 2017
Registration decision: 06 February 2018
Date registered: 09 February 2018
nivolumab
Bristol-Myers Squibb Australia Pty Ltd
Opdivo, as monotherapy, is now also indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. The approval of this indication is based on objective response rate and duration of response in a single arm study.
January 2018
ALECENSA 
Evaluation commenced: 7 Sep 2017
Registration decision: 30 Jan 2018
Date registered: 30 Jan 2018
alectinib hydrochloride
Roche Products Pty Limited
Alecensa is now also indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
VYVANSE
Evaluation commenced: 30 Jun 2016
Registration decision: 22 Jan 2018
Date registered: 24 Jan 2018
lisdexamfetamine dimesilate
Shire Australia Pty Ltd
Vyvanse is now also indicated for the treatment of moderate to severe Binge Eating Disorder (BED) in adults when nonpharmacological treatment is unsuccessful or unavailable. Treatment should be commenced and managed by a psychiatrist.
REVLIMID
Evaluation commenced: 31 Mar 2017
Registration decision: 17 Jan 2018
Date registered: 19 Jan 2018
lenalidomide
Celgene Pty Ltd
Revlimid is now also indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
ORENCIA
Evaluation commenced: 10 Jan 2017
Registration decision: 10 Jan 2018
Date registered: 12 Jan 2018
abatacept (rch)
Bristol-Myers Squibb Australia Pty Ltd
Orencia is now also indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Orencia can be used with or without non-biologic DMARDs.
KEYTRUDA
Evaluation commenced: 28 Feb 2017
Registration decision: 9 Jan 2018
Date registered: 11 Jan 2018
pembrolizumab (rch)
Merck Sharp & Dohme (Australia) Pty Ltd
Keytruda is now also indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
- are not eligible for cisplatin-containing therapy. This indication is approved based on overall response rate and duration of response. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established; or
- have received platinum-containing chemotherapy
SAXENDA
Evaluation commenced: 1 Feb 2017
Registration decision: 5 Jan 2018
Date registered: 8 Jan 2018
liraglutide (rys)
Novo Nordisk Pharmaceuticals Pty Ltd
Saxenda is now also indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:
- ≥ 30 kg/m2 (obese); or
- ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.
VICTOZA
Evaluation commenced: 1 Feb 2017
Registration decision: 5 Jan 2018
Date registered: 8 Jan 2018
liraglutide (rys)
Novo Nordisk Pharmaceuticals Pty Ltd
Victoza is now also indicated for:
- Glycaemic control: Victoza is indicated as an adjunct to diet and exercise for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as monotherapy when metformin is contraindicated or is not tolerated.
- Prevention of cardiovascular events: In patients where Victoza is indicated to improve glycaemic control, Victoza is indicated to reduce the risk of cardiovascular events in those at high cardiovascular risk, as an adjunct to standard of care therapy.
AFINITOR
Evaluation commenced: 31 Jan 2017
Registration decision: 22 Dec 2017
Date registered: 3 Jan 2018
everolimus
Novartis Pharmaceuticals Australia Pty Ltd
Afinitor is now also indicated for the adjunctive treatment of patients aged 2 years and older with Tuberous Sclerosis Complex (TSC) and associated refractory seizures.