Prescription medicines under evaluation
Search applications for new medicines or new uses of existing medicines that are under our evaluation. This does not guarantee registration or Pharmaceutical Benefits Scheme (PBS) entry.
Application types:
- Application type A: applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia
- Application type B: applications for a 'new combination', where two or more already approved medicines are combined into a single product
- Application type C: applications for a 'new indication', or additional therapeutic use, for an already approved medicine.
For more information visit Prescription medicines: applications under evaluation.
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Application type
Sponsor
- AstraZeneca Pty Ltd (10)
- Novartis Pharmaceuticals Australia Pty Ltd (8)
- AbbVie Pty Ltd (7)
- Merck Sharp & Dohme (Australia) Pty Ltd (7)
- Eli Lilly Australia Pty Ltd (4)
- Sanofi-Aventis Australia Pty Ltd (4)
- Bayer Australia Ltd (3)
- BeOne Medicines AUS Pty Ltd (3)
- GlaxoSmithKline Australia Pty Ltd (3)
- Moderna Australia Pty Ltd (3)
- Pfizer Australia Pty Ltd (3)
- Seqirus Pty Ltd (3)
- AFT Pharmaceuticals Pty Ltd (2)
- Astellas Pharma Australia Pty Ltd (2)
- Bristol-Myers Squibb Australia Pty Ltd (2)
- Chiesi Australia Pty Ltd (2)
- Dr Reddys Laboratories Australia Pty Ltd (2)
- Janssen-Cilag Pty Ltd (2)
- Novo Nordisk Pharmaceuticals Pty Ltd (2)
- ORGANON PHARMA PTY LTD (2)
- Reach Pharmaceuticals Pty Ltd (2)
- Roche Products Pty Ltd (2)
- Servier Laboratories (Aust) Pty Ltd (2)
- Viatris Pty Ltd (2)
- AA-Med Pty Ltd (1)
- Accelagen Pty Ltd (1)
- Accelera Biopharma Pty Ltd (1)
- Acumen Dental Unit Trust (1)
- Alexion Pharmaceuticals Australasia Pty Ltd (1)
- Amgen Australia Pty Ltd (1)
- Amivas Australia Pty Ltd (1)
- Anthia Life Sciences Pty Ltd (1)
- Besins Healthcare Australia Pty Ltd (1)
- Boehringer Ingelheim Pty Ltd (1)
- Cipla Australia Pty Ltd (1)
- CSL Behring (Australia) Pty Ltd (1)
- DKSH Healthcare Australia Pty Ltd (1)
- Dr Falk Pharma Australia Pty Ltd (1)
- Fresenius Medical Care Australia Pty Ltd (1)
- Gilead Sciences Pty Ltd (1)
- Global Medical Solutions Australia Pty Limited (1)
- HL Pharma Pty Ltd (1)
- Innocare Pharma Australia Pty Ltd (1)
- Ipsen Pty Ltd (1)
- Lacuna Pharma Pty Ltd (1)
- Maxx Pharma Pty Ltd (1)
- Mayne Pharma International Pty Ltd (1)
- Medison Pharma Australia Pty Ltd (1)
- MS Health Pty Ltd (1)
- Orion Pharma (AUS) Pty Limited (1)
- Otsuka Australia Pharmaceutical Pty Ltd (1)
- Pharming Australia Pty Ltd (1)
- Southern XP IP Pty Ltd (1)
- Specialised Therapeutics Alim Pty Ltd (1)
- Teva Pharma Australia Pty Ltd (1)
- ViiV Healthcare Pty Ltd (1)
- Vitalis Therapeutics (1)
Search
115 result(s) found, displaying 1 to 25
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May-2026Prescription medicine evaluationActive ingredient: ianalumab.
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May-2026Prescription medicine evaluationActive ingredient: gefurulimab.
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Apr-2026Prescription medicine evaluationActive ingredient: tegoprazan.
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Apr-2026Prescription medicine evaluationActive ingredient: upadacitinib hemihydrate.
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Apr-2026Prescription medicine evaluationActive ingredient: recombinant respiratory syncytial virus pre-fusion F protein, water for injections.
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Apr-2026Prescription medicine evaluationActive ingredient: avibactam sodium, aztreonam.
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Apr-2026Prescription medicine evaluationActive ingredient: pembrolizumab.
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Apr-2026Prescription medicine evaluationActive ingredient: enfortumab vedotin.
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Apr-2026Prescription medicine evaluationActive ingredient: zanidatamab.
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Apr-2026Prescription medicine evaluationActive ingredient: trastuzumab deruxtecan.
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Apr-2026Prescription medicine evaluationActive ingredient: pembrolizumab.
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Apr-2026Prescription medicine evaluationActive ingredient: pembrolizumab.
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Apr-2026Prescription medicine evaluationActive ingredient: cemiplimab.
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Apr-2026Prescription medicine evaluationActive ingredient: rapamycin/sirolimus.
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Apr-2026Prescription medicine evaluationActive ingredient: tislelizumab.
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Apr-2026Prescription medicine evaluationActive ingredient: sacituzumab govitecan.
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Apr-2026Prescription medicine evaluationActive ingredient: belzutifan.
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Apr-2026Prescription medicine evaluationActive ingredient: obinutuzumab.
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Mar-2026Prescription medicine evaluationActive ingredient: dexamethasone sodium phosphate.
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Mar-2026Prescription medicine evaluationActive ingredient: inclisiran.
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Mar-2026Prescription medicine evaluationActive ingredient: gallium (68Ga) chloride, germanium (68Ge) chloride.
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Mar-2026Prescription medicine evaluationActive ingredient: idebenone.
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Mar-2026Prescription medicine evaluationActive ingredient: SARS-CoV-2 JN.1 mRNA, influenza virus haemagglutinin mRNA.
Last updated