Prescription medicines: registration of new chemical entities in Australia, 2017

inactivated trivalent influenza vaccine (Split Virion)

Sanofi-Aventis Australia Pty Ltd

Fluzone High-Dose is indicated for active immunisation against influenza disease caused by influenza virus types A and B contained in the vaccine for use in persons 65 years of age and older.

patiromer sorbitex calcium

Vifor Pharma Pty Ltd

Veltassa is indicated for the treatment of hyperkalaemia in adults.

ferric derisomaltose

Link Medical Products Pty Ltd

Monofer is indicated for the treatment of iron deficiency in adults, under the following conditions:

• When oral iron preparations are ineffective or cannot be used;
• Where there is a clinical need to deliver iron rapidly.

The diagnosis must be based on laboratory tests.

insulin degludec (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

Tresiba Flextouch and Tresiba Penfill are indicated to improve glycaemic control in adult patients with diabetes mellitus requiring insulin.

70% insulin degludec (rys) / 30% insulin aspart (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

Ryzodeg 70/30 Flextouch and Ryzodeg 70/30 Penfill are indicated to improve glycaemic control in adult patients with diabetes mellitus requiring basal and prandial insulin.

bezlotoxumab (rch)

Merck Sharp & Dohme Australia Pty Ltd

Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adult patients 18 years or older at high risk for recurrence of CDI who are receiving antibiotic therapy for CDI. Zinplava should only be used in conjunction with antibacterial drug treatment of CDI.

nusinersen (as heptadecasodium)

Biogen Australia Pty Ltd

Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy (SMA).

influenza virus haemagglutinin vaccine

Mylan Health Pty Ltd

Influvac Tetra is indicated for the prevention of influenza caused by influenza virus, types A and B, in adults (18 years of age and older).

pegaspargase

Baxalta Australia Pty Ltd

Oncaspar is indicated as a component of antineoplastic combination therapy in patients with Acute Lymphoblastic Leukaemia (ALL).

ribociclib (as succinate)

Novartis Pharmaceuticals Australia Pty Ltd

Kisqali, in combination with an aromatase inhibitor, is indicated for the treatment of men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer, as an initial endocrine-based therapy.

ranolazine

A. Menarini Australia Pty Ltd

Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of stable angina pectoris in patients taking maximum tolerated doses of a beta-blocker or a calcium channel blocker and have inadequate symptom control.

meningococcal group B vaccine

Pfizer Australia Pty Ltd

Trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

fosfomycin trometamol

Mayne Pharma International Pty Ltd

Monurol is indicated only for the treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in females above 12 years of age caused by the following susceptible pathogens: Enterobacteriaceae (including Escherichia coli), Enterococcus faecalis.

guanfacine (as hydrochloride)

Shire Australia Pty Ltd

Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants). Intuniv must be used as part of a comprehensive ADHD management programme, typically including psychological, educational and social measures.

migalastat (as hydrochloride)

ERA Consulting (Australia) Pty Ltd

Galafold is indicated for long-term treatment of adult and adolescent patients 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.

atezolizumab (rch)

Roche Products Pty Ltd

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

reslizumab

Teva Pharma Australia Pty Ltd

Cinqair/Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma (blood eosinophil count ≥400 cells/μL).

Dengue tetravalent vaccine-live, attenuated

Sanofi-Aventis Australia Pty Ltd

Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 through 45 years of age living in endemic areas.

daratumumab

Janssen-Cilag Pty Ltd

Darzalex / Janssen Daratumumab is indicated:

• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy;
• as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent.

ocrelizumab

Roche Products Pty Ltd

Ocrevus is indicated for the treatment of patients with:

• relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and to reduce the frequency of relapse;
• primary progressive multiple sclerosis (PPMS) to delay the progression of physical disability.

sodium phenylbutyrate

Orpharma Pty Ltd

Pheburane is indicated for the management of hyperammonaemia associated with urea cycle disorders. Pheburane should be used with dietary protein restriction and, in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, and protein-free calorie supplements).

trifluridine/tipiracil hydrochloride

Servier Laboratories (Aust) Pty Ltd

Lonsurf/Orcantas is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

silodosin

Mayne Pharma International Pty Ltd

Urorec is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia in adult men.

brexipiprazole

Lundbeck Australia Pty Limited

Rexulti is indicated in adult patients for the treatment of schizophrenia.

teduglutide

Shire Australia Pty Ltd

Revestive is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy.

sebelipase alfa rce

Alexion Pharmaceuticals Australasia Pty Ltd

Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase deficiency (LAL-D).

palbociclib

Pfizer Australia Pty Ltd

Ibrance is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

• an aromatase inhibitor as initial endocrine-based therapy
• fulvestrant in patients who have received prior therapy.

lonoctocog alfa (recombinant single-chain coagulation factor VIII)

CSL Behring Australia Pty Ltd

Afstyla is indicated in adult and paediatric patients with haemophilia A (congenital FVIII deficiency) for:

• Control and prevention of bleeding episodes
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
• Perioperative management (surgical prophylaxis).

Afstyla is not indicated for the treatment of von Willebrand disease.

follitropin delta (rhu)

Ferring Pharmaceuticals Pty Ltd

Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

rurioctocog alfa pegol (antihaemophilic factor VIII Recombinant Coagulation Factor VIII rch)

Baxalta Australia Pty Ltd

Adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia A (congenital factor VIII deficiency) patients for:

• Control and prevention of bleeding episodes
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
• Perioperative management (surgical prophylaxis).

It is not indicated for the treatment of von Willebrand disease.

alectinib

Roche Products Pty Ltd

For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

standardised allergen extract of grass pollen from Timothy grass (Phleum pratense)

Seqirus Pty Ltd

For disease modifying treatment of grass pollen (Phleum pratense or allergens cross reacting with P. pratense) induced allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age of 5 years.

human alpha-1-proteinase inhibitor

CSL Behring Australia Pty Ltd

For maintenance treatment to slow the progression of emphysema in adults with documented severe A1-PI deficiency and progressive lung disease.

venetoclax

Abbvie Pty Ltd

For the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p deletion, or patients with relapsed or refractory CLL for whom there are no other suitable treatment options.

Previous years

 2016 2015 2014

Prescription medicines registrations database from 2018 onwards

Visit our Prescription medicines registrations database to see the registration of NCEs for each year from 2018 onwards.

Prescription medicines registrations