Prescription medicines: new or extended uses, or new combinations of registered medicines, 2016

Related information

20 March 2017

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 orphan drug

2016: Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan

December 2016

'Extension of Indications' registrations, December 2016
Medicine Date registered

BOOSTRIX

combined diphtheria-tetanus-acellular pertussis (dTpa) vaccine

Sponsor: GlaxoSmithKline Australia Pty Ltd

For booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older.

22 December 2016

CUBICIN

daptomycin

Sponsor: Merck Sharp & Dohme (Australia) Pty Ltd

For the treatment of adults and paediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI).

22 December 2016

JARDIAMET

empagliflozin / metformin hydrochloride

Sponsor: Boehringer Ingelheim Pty Ltd

As an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate.

19 December 2016

DUAVIVE

conjugated estrogens / bazedoxifene acetate

Sponsor: Pfizer Australia Pty Ltd

Duavive (conjugated estrogens / bazedoxifene acetate fixed-dose combination) is indicated for treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.

  • Duavive should be used for the shortest duration consistent with treatment goals and risks for the individual woman.
  • Experience in women older than 65 years is limited.
15 December 2016

IMBRUVICA/JANSSEN IBRUTINIB

ibrutinib

Sponsor: Janssen-Cilag Pty Ltd

  • Imbruvica/Janssen Ibrutinib is now also indicated for the treatment of adult patients with Waldenstrom’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first-line treatment of patients unsuitable for combination chemo-immunotherapy; and
  • Adult patients with CLL/SLL who have received at least one prior therapy, or adult patients with previously untreated CLL/SLL (see CLINICAL TRIALS).
15 December 2016

EVICEL

fibrinogen / thrombin (human)

Sponsor: Johnson & Johnson Medical Pty Ltd

Evicel is now also indicated for suture line sealing in dura mater closure.

9 December 2016

NOCDURNA

desmopressin (as acetate)

Sponsor: Ferring Pharmaceuticals Pty Ltd

Nocdurna is now indicated for the treatment of nocturia due to idiopathic nocturnal polyuria in adults who awaken two or more times each night to void and have not responded to lifestyle measures.

Nocturnal polyuria should be confirmed on the basis of a 24 hour urine frequency-volume diary. It is defined as > 33% of urine passed overnight. Secondary causes of nocturia should be excluded (see CONTRAINDICATIONS and PRECAUTIONS).

2 December 2016

November 2016

'Extension of Indications' registrations, November 2016
Medicine Date registered

TECHNIVIE

paritaprevir / ritonavir / ombitasvir

Sponsor: AbbVie Pty Ltd

Technivie is indicated in combination with ribavirin for the treatment of adult patients with genotype 4 chronic hepatitis C virus (HCV) infection.

30 November 2016

HALAVEN

eribulin mesilate

Sponsor: Eisai Australia Pty Ltd

Halaven is now also indicated for the treatment of patients with unresectable liposarcoma who have received prior chemotherapy for advanced or metastatic disease.

18 November 2016

OPDIVO

nivolumab

Sponsor: Bristol-Myers Squibb Australia Pty Ltd

Opdivo is now also indicated as monotherapy for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy in adults.

18 November 2016

HARVONI

ledipasvir / sofosbuvir

Sponsor: Gilead Sciences Pty Ltd

HARVONI (ledipasvir/sofosbuvir fixed-dose combination) is indicated for the treatment of chronic hepatitis C (CHC) infection in adults.

(see PRECAUTIONS and CLINICAL TRIALS sections for information on the available data for HCV patients of each genotype, see DOSAGE AND ADMINISTRATION section for recommended regimens and treatment durations for different patient subgroups).

16 November 2016

October 2016

'Extension of Indications' registrations, October 2016
Medicine Date registered

ONGLYZA

saxagliptin (as hydrochloride)

Sponsor: AstraZeneca Pty Ltd

Onglyza is now also indicated for use in patients with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicines, when these together with diet and exercise, do not provide adequate glycaemic control.

31 October 2016

HUMIRA orphan drug

adalimumab (rch)

Sponsor: Abbvie Pty Ltd

Humira is now also indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

25 October 2016

QTERN 5/10

saxagliptin (as hydrochloride) / dapagliflozin (as propanediol monohydrate)

Sponsor: AstraZeneca Pty Ltd

Qtern 5/10 is indicated as an adjunct to diet and exercise, in combination with metformin, to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and dapagliflozin is appropriate.

25 October 2016

September 2016

'Extension of Indications' registrations, September 2016
Medicine Date registered

INVEGA TRINZA

paliperidone (as palmitate)

Sponsor: Janssen-Cilag Pty Ltd

Invega Trinza is a 3-month injection for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months.

23 September 2016

ADCETRIS orphan drug

brentuximab vedotin (rch)

Sponsor: Takeda Pharmaceuticals Australia Pty Ltd

Adcetris is now also indicated for the treatment of adult patients with CD30+ Hodgkin lymphoma (HL) at higher risk of relapse or progression following ASCT.

20 September 2016

SIMPONI

golimumab (rmc)

Sponsor: Janssen-Cilag Pty Ltd

Simponi is now also indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-Axial SpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs (NSAIDs).

9 September 2016

ALPROLIX orphan drug

eftrenonacog alfa (rhu)

Sponsor: Biogen Australia Pty Ltd

Alprolix is now also indicated for use in children 12 years of age or under with haemophilia B.

7 September 2016

August 2016

'Extension of Indications' registrations, August 2016
Medicine Date registered

ODEFSEY

emtricitabine / rilpivirine / tenofovir alafenamide

Gilead Sciences Pty Ltd

For use as a complete regimen for the treatment of HIV-1 infection in adults and adolescents (12 years and older with body weight at least 35 kg) with plasma HIV-1 RNA <= 100,000 copies/mL at the start of therapy. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of ODEFSEY.

GAZYVA

obinutuzumab (rch)

Sponsor: Roche Products Pty Ltd

Gazyva can now also be used in combination with bendamustine, following Gazyva maintenance, for use in the treatment of patients with follicular lymphoma (FL) who did not respond to, or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

30 August 2016

ABILIFY MAINTENA

aripiprazole (as monohydrate)

Sponsor: Lundbeck Australia Pty Ltd

Abilify Maintena is now also indicated for the acute treatment of schizophrenia in adults.

10 August 2016

July 2016

'Extension of Indications' registrations, July 2016
Medicine Date registered

TARGIN

oxycodone hydrochloride/naloxone hydrochloride

Mundipharma Pty Ltd

Targin is now also indicated for second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

20 July 2016

HUMIRA

adalimumab

Abbvie Pty Ltd

Humira is now also indicated for the treatment of:

  • enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.
  • moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
  • severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.
18 July 2016

LATISSE

bimatoprost

Allergan Australia Pty Ltd

Latisse is indicated to treat hypotrichosis of the eye lashes in adults by increasing their growth including, but not necessarily all of, length, thickness and darkness.

14 July 2016

UTROGESTAN

progesterone

Besins Healthcare Australia Pty Ltd

Utrogestan is indicated for Luteal Support of Assisted Reproductive Technology (ART) cycles.

12 July 2016

DESCOVY

emtricitabine and tenofovir alafenamide fumarate

Sponsor: Gilead Sciences Pty Ltd

Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight at least 35 kg.

1 July 2016

June 2016

'Extension of Indications' registrations, June 2016
Medicine Date registered

PROMETRIUM

progesterone

Sponsor: Besins Healthcare Australia Pty Ltd

Prometrium is indicated for use in women with menstrual abnormalities or secondary amenorrhoea due to normogonadotrophic amenorrhoea and for adjunctive use with an oestrogen for hormone replacement therapy in postmenopausal women with an intact uterus.

20 June 2016

GLYPRESSIN orphan drug

terlipressin

Sponsor: Ferring Pharmaceuticals Pty Ltd

Glypressin is now also indicated for the treatment of patients with hepatorenal syndrome (HRS) Type 1 to improve short-term survival where liver transplant is being actively considered.

10 June 2016

May 2016

'Extension of Indications' registrations, May 2016
Medicine Date registered

PERJETA

pertuzumab (rch)

Sponsor: Roche Products Pty Ltd

Perjeta is now also indicated, in combination with trastuzumab and chemotherapy, for the neoadjuvant treatment of patients with inflammatory or locally advanced HER2-positive breast cancer as part of a complete treatment regimen.

20 May 2016

ESMYA

ulipristal acetate

Sponsor: ERA Consulting (Australia) Pty Ltd

Esmya containing ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

17 May 2016

FYCOMPA

perampanel (as hemisesquihydrate)

Sponsor: Eisai Australia Pty Ltd

Fycompa is now indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.

13 May 2016

COSENTYX

secukinumab

Sponsor: Novartis Pharmaceuticals Australia Pty Ltd

Cosentyx is now also indicated for the treatment of:

  • adult patients with active psoriatic arthritis when the response to previous disease- modifying anti-rheumatic drug (DMARD) therapy has been inadequate and,
  • for active ankylosing spondylitis.
12 May 2016

TRUVADA

tenofovir disoproxil fumarate / emtricitabine

Sponsor: Gilead Sciences Pty Ltd

Truvada is now also indicated, in combination with safer sex practices, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

6 May 2016

April 2016

'Extension of Indications' registrations, April 2016
Medicine Date registered

EVIPLERA

tenofovir disoproxil fumarate / emtricitabine / rilpivirine [as hydrochloride]

Sponsor: Gilead Sciences Pty Ltd

Eviplera is now indicated for use in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen.

29 April 2016

HUMIRA

adalimumab (rch)

Sponsor: AbbVie Pty Ltd

Humira is now indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

8 April 2016

NOLVADEX/NOLVADEX-D

tamoxifen as citrate

Sponsor: AstraZeneca Pty Ltd

Nolvadex/Nolvadex-D is now indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).

8 April 2016

ELOCTATE orphan drug

efmoroctocog alfa (rhu)

Sponsor: Biogen Australia Pty Ltd

Eloctate is now indicated for use in children with haemophilia A.

6 April 2016

March 2016

'Extension of Indications' registrations, March 2016
Medicine Date registered

REVOLADE orphan drug

eltrombopag

Sponsor: Novartis Pharmaceuticals Aust Pty Ltd

Revolade is now indicated for the treatment of paediatric patients with chronic immune thrombocytopaenia (ITP) who have failed other treatments and either a) need an increased platelet concentration for a planned procedure or b) who are at a high risk of clinically significant bleeding.

30 March 2016

KALYDECO orphan drug

ivacaftor

Sponsor: Vertex Pharmaceuticals Australia Pty Ltd

Kalydeco is now indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have an R117H mutation in the CFTR gene.

29 March 2016

XIAFLEX

collagenase clostridium histolyticum

Sponsor: Actelion Pharmaceutical Australia Pty Ltd

Xiaflex is now indicated for treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

21 March 2016

REVLIMID orphan drug

lenalidomide

Sponsor: Celegene Pty Ltd

Revlimid is now indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

16 March 2016

February 2016

'Extension of Indications' registrations, February 2016
Medicine Date registered

EYLEA

aflibercept (rch)

Sponsor: Bayer Australia Ltd

Eylea is now indicated in adults for the treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV).

26 February 2016

OPDIVO

Nivolumab

Sponsor: Bristol-Myers Squibb Australia Pty Ltd

Opdivo, is now also indicated as monotherapy for the treatment of locally advanced or metastatic non squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. In patients with tumour EGFR or ALK genomic aberrations, Opdivo should be used after progression on or after targeted therapy.

17 February 2016

VOLIBRIS orphan drug

ambrisentan

Sponsor: GlaxoSmithKline Australia Pty Ltd

Volibris in combination with tadalafil is now indicated for the treatment of WHO Group 1 pulmonary arterial hypertension in patients with WHO functional class II, III or IV symptoms.

16 February 2016

VICTOZA

liraglutide (rys)

Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd

Victoza is now indicated for combination therapy with basal insulin, with or without metformin, as an adjunct to diet and exercise, for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control.

3 February 2016

XOLAIR

omalizumab (rch)

Sponsor: Novartis Pharmaceuticals Australia Pty Limited

Xolair is now indicated for use in children aged 6 to <12 years as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range.

2 February 2016

January 2016

There were no entries for the month of January.