Prescription medicines: new or extended uses, or new combinations of registered medicines, 2017

regorafenib

Bayer Australia Ltd

Stivarga is now also indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

crizotinib

Pfizer Australia Pty Ltd

Xalkori is now also indicated for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).

cladribine

Merck Serono Australia Pty Ltd

Mavenclad is now also indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability. Following completion of the 2 treatment courses, no further treatment is required in years 3 and 4. Re-initiation of therapy after year 4 has not been studied.

aripiprazole as monohydrate

Lundbeck Australia Pty Ltd

Abilify Maintena is now also indicated for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy.

obinutuzumab

Roche Products Pty Ltd

Gazyva, in combination with chemotherapy followed by Gazyva maintenance, is now also indicated for the treatment of patients with previously untreated advanced follicular lymphoma.

nilotinib

Novartis Pharmaceuticals Australia Pty Ltd

Tasigna is indicated for the treatment of adult patients with:

• newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (CML) in chronic phase;
• chronic phase and accelerated phase Philadelphia chromosome positive CML that is resistant to or intolerant of prior therapy including imatinib.

bevacizumab

Roche Products Pty Limited

Avastin, in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is now also indicated for the treatment of platinum-sensitive epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.

tocilizumab (rch)

Roche Products Pty Limited

Actemra is now also indicated for the treatment of giant cell arteritis (GCA) in adult patients.

insulin glargine (rbe) and lixisenatide

Sanofi-Aventis Australia Pty Ltd

Soliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

leuprorelin

Tolmar Australia Pty Ltd

Eligard is now also indicated for the treatment of high-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy.

alirocumab (rch)

Sanofi Aventis Australia Pty Ltd

Praluent is indicated as an adjunct to diet and exercise to reduce LDL-cholesterol (LDL-C) in adults with one or more of: heterozygous familial hypercholesterolaemia, clinical atherosclerotic cardiovascular disease, or hypercholesterolemia with high or very high cardiovascular risk.

• In combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with maximum tolerated dose of a statin or,
• In combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach LDL-C goals.

pembrolizumab (rch)

Merck Sharp & Dohme (Australia) Pty Limited

Keytruda as monotherapy is now also indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin Lymphoma (cHL): 1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

indacaterol (as maleate) / glycopyrronium (as bromide)

Novartis Pharmaceuticals Australia Pty Ltd

Ultibro Breezhaler 110/50 is now also indicated for the reduction of exacerbations of chronic obstructive pulmonary disease (COPD) in patients with a history of exacerbations.

nadroparin calcium

Aspen Pharmacare Australia Pty Ltd

Fraxiparine is now also indicated for the prophylaxis of venous thromboembolism in high-risk medical patients who are immobilised due to acute illness or hospitalised in an intensive care unit.

palonosetron as hydrochloride

Mundipharma Pty Ltd

Aloxi is now also indicated for prevention of post-operative nausea and vomiting (PONV) for up to 24 hours following surgery.

ranibizumab (rbe)

Novartis Pharmaceuticals Australia Pty Ltd

Lucentis is now also indicated in adults for the treatment of visual impairment due to choroidal neovascularisation.

blinatumomab

Amgen Australia Pty Ltd

Blincyto is now also indicated for the treatment of paediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

lenvatinib

Eisai Australia Pty Limited

Lenvima is now also indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

Opdivo as monotherapy is now also indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy.

linagliptin / metformin hydrochloride

Boehringer Ingelheim Pty Ltd

Trajentamet is now also indicated in combination with a sodium-dependent glucose co-transporter-2 (SGLT2) inhibitor (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an SGLT2 inhibitor.

linagliptin

Boehringer Ingelheim Pty Ltd

Trajenta is now also indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in conjunction with diet and exercise, as add on to metformin plus a sodium-dependent glucose co-transporter-2 (SGLT2) inhibitor.

meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccines

GlaxoSmithKline Australia Pty Ltd

Menveo is now also indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W135 and Y.

dexamethasone

Allergan Australia Pty Ltd

Ozurdex is now also indicated for the treatment of macular oedema due to Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO), and also indicated for non-infectious uveitis affecting the posterior segment of the eye.

tofacitinib (as citrate)

Pfizer Australia

Xeljanz is now also indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. Xeljanz can be used alone or in combination with nonbiological DMARDs, including methotrexate.

imiglucerase-rch

Sanofi-Aventis Australia Pty Ltd

Cerezyme is now also indicated for long-term enzyme replacement therapy for patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease.

nivolumab

Bristol-Myers Squibb Aust Pty Ltd

Opdivo, as monotherapy, is now also indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant and treatment with brentuximab vedotin.

ezetimibe and atorvastatin

Merck Sharp & Dohme (Australia) Pty Limited

Atozet/Zeteze is now also indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of low-density lipoprotein cholesterol (LDL-C) in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.

empagliflozin / metformin hydrochloride

Boehringer Ingelheim Pty Ltd

Empagliflozin is now also indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death. To prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

paritaprevir/ritonavir/ombitasvir & dasabuvir & ribavirin

AbbVie Pty Ltd

For the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis. Duration of therapy and addition of ribavirin are dependent on patient population.

paritaprevir/ritonavir/ombitasvir & dasabuvir

AbbVie Pty Ltd

For the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis. Duration of therapy and addition of ribavirin are dependent on patient population.

tolvaptan

Otsuka Australia Pharmaceutical Pty Ltd

To slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.

pembrolizumab (rch)

Merck Sharp & Dohme (Australia) Pty Limited

For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. 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.

ibuprofen

Emerge Health Pty Ltd

For the treatment of haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

adapalene / benzoyl peroxide

Galderma Australia Pty Ltd

For the cutaneous treatment of acne vulgaris, when comedones, numerous papules and pustules are present in patients 12 years of age and older and the condition has not responded to first line treatment.

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Limited

For the treatment of patients with advanced non-small cell lung carcinoma (NSCLC) whose tumours express programmed death-ligand 1 (PD-L1) with a ≥1% tumour proportion score (TPS) as determined by a validated test and who have received platinum-containing chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving Keytruda.

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Limited

For the first-line treatment of patients with metastatic non-small cell lung carcinoma (NSCLC) whose tumours express programmed death-ligand 1 (PD-L1) with a ≥50% tumour proportion score (TPS) as determined by a validated test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

ustekinumab

Janssen-Cilag Pty Ltd

For the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response, were intolerant to conventional therapy or a TNF alpha antagonist or have medical contraindications to such therapies.

tenofovir alafenamide (as fumarate)

Gilead Sciences Pty Ltd

For the treatment of chronic hepatitis B in adults.

idelalisib

Gilead Sciences Pty Ltd

For use, in combination with ofatumumab, for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) upon relapse in patients for whom chemo-immunotherapy is not considered suitable.

certolizumab pegol (rbe)

UCB Australia Pty Ltd

For use in combination with methotrexate (MTX) for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX or other disease-modifying antirheumatic drugs (DMARDs).

ezetimibe/simvastatin

Merck Sharp & Dohme (Australia) Pty Limited

For use in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.

ezetimibe

Merck Sharp & Dohme (Australia) Pty Limited

For administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.

everolimus

Novartis Pharmaceuticals Aust Pty Ltd

For the treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults.

empagliflozin

Boehringer Ingelheim Pty Ltd

To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease.

amoxicillin sodium and clavulanic acid

Juno Pharmaceuticals Pty Ltd

As an antibiotic alternative to narrow- and broad-spectrum antibiotics for the treatment of infections.

nitric oxide

Biotech Regulatory Solutions

In conjunction with ventilator support and other appropriate active substances to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery.

dapsone

Allergan Australia Pty Ltd

For the topical treatment of acne vulgaris in patients 12 years of age and older.

Prescription medicines registrations database from 2018 onwards

Visit our Prescription medicines registrations database to see registrations for new or extended uses, or new combinations of registered medicines, by year from 2018 onwards.

Prescription medicines registrations

Previous years

2016