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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- AbbVie Pty Ltd (8)
- AstraZeneca Pty Ltd (7)
- Novartis Pharmaceuticals Australia Pty Ltd (7)
- Merck Sharp & Dohme (Australia) Pty Ltd (6)
- Bayer Australia Ltd (4)
- Eli Lilly Australia Pty Ltd (4)
- Pfizer Australia Pty Ltd (4)
- Sanofi-Aventis Australia Pty Ltd (4)
- Dr Reddys Laboratories Australia Pty Ltd (3)
- Roche Products Pty Ltd (3)
- Viatris Pty Ltd (3)
- AFT Pharmaceuticals Pty Ltd (2)
- Astellas Pharma Australia Pty Ltd (2)
- BeOne Medicines AUS Pty Ltd (2)
- Boehringer Ingelheim Pty Ltd (2)
- Bristol-Myers Squibb Australia Pty Ltd (2)
- Gilead Sciences Pty Ltd (2)
- GlaxoSmithKline Australia Pty Ltd (2)
- Janssen-Cilag Pty Ltd (2)
- Merck Healthcare Pty Ltd (2)
- Moderna Australia Pty Ltd (2)
- Novo Nordisk Pharmaceuticals Pty Ltd (2)
- Seqirus Pty Ltd (2)
- Sun Pharma ANZ Pty Ltd (2)
- Vitalis Therapeutics (2)
- AA-Med Pty Ltd (1)
- Accelera Biopharma Pty Ltd (1)
- Actor Pharmaceuticals 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)
- Aspen Pharmacare Australia Pty Ltd (1)
- Besins Healthcare Australia Pty Ltd (1)
- Chiesi Australia Pty Ltd (1)
- CSL Behring (Australia) Pty Ltd (1)
- DKSH Healthcare Australia Pty Ltd (1)
- Dr Falk Pharma Australia Pty Ltd (1)
- Echo Therapeutics Pty Ltd (1)
- Fresenius Medical Care Australia Pty Ltd (1)
- Glenmark Pharmaceuticals Australia Pty Ltd (1)
- Global Medical Solutions Australia Pty Limited (1)
- HL Pharma Pty Ltd (1)
- Ipsen Pty Ltd (1)
- Jazz Pharmaceuticals ANZ 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)
- ORGANON PHARMA PTY LTD (1)
- Pharming Australia Pty Ltd (1)
- Reach Pharmaceuticals Pty Ltd (1)
- Regulatory Services Australia (1)
- Southern XP IP Pty Ltd (1)
- Specialised Therapeutics Alim Pty Ltd (1)
- Specialised Therapeutics Pharma Pty Ltd (1)
- Sublux P/L (1)
- Swedish Orphan Biovitrum Pty Ltd (1)
- Taiho Pharma Oceania Pty Ltd (1)
- Takeda Pharmaceuticals Australia Pty Ltd (1)
- Teva Pharma Australia Pty Ltd (1)
- ViiV Healthcare Pty Ltd (1)
Search
120 result(s) found, displaying 101 to 120
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Oct-2025Prescription medicine evaluationActive ingredient: elinzanetant.
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Sep-2025Prescription medicine evaluationActive ingredient: norucholic acid.
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Sep-2025Prescription medicine evaluationActive ingredient: benralizumab.
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Sep-2025Prescription medicine evaluationActive ingredient: toripalimab.
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Sep-2025Prescription medicine evaluationActive ingredient: drospirenone.
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Sep-2025Prescription medicine evaluationActive ingredient: mifepristone, misoprostol.
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Sep-2025Prescription medicine evaluationActive ingredient: onasemnogene abeparvovec.
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Sep-2025Prescription medicine evaluationActive ingredient: gadoquatrane.
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Sep-2025Prescription medicine evaluationActive ingredient: tirzepatide.
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Sep-2025Prescription medicine evaluationActive ingredient: Semaglutide.
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Sep-2025Prescription medicine evaluationActive ingredient: Bempedoic acid, ezetimibe.
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Jul-2025Prescription medicine evaluationActive ingredient: oxymetazoline hydrochloride.
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Jul-2025Prescription medicine evaluationActive ingredient: camizestrant.
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Jun-2025Prescription medicine evaluationActive ingredient: calcium chloride dihydrate.
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Jun-2025Prescription medicine evaluationActive ingredient: dydrogesterone.
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Jun-2025Prescription medicine evaluationActive ingredient: retifanlimab.
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May-2025Prescription medicine evaluationActive ingredient: diltiazem hydrochloride.
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Feb-2025Prescription medicine evaluationActive ingredient: teplizumab.
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Sep-2024Prescription medicine evaluationActive ingredient: lidocaine hydrochloride.
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Aug-2024Prescription medicine evaluationActive ingredient: Artesunate.
Last updated