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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 (5)
- Eli Lilly Australia Pty Ltd (5)
- Janssen-Cilag Pty Ltd (5)
- Accelagen Pty Ltd (4)
- Merck Sharp & Dohme (Australia) Pty Ltd (4)
- Novartis Pharmaceuticals Australia Pty Ltd (4)
- Takeda Pharmaceuticals Australia Pty Ltd (4)
- AbbVie Pty Ltd (3)
- AFT Pharmaceuticals Pty Ltd (3)
- Bayer Australia Ltd (3)
- Bristol-Myers Squibb Australia Pty Ltd (3)
- Seqirus Pty Ltd (3)
- Gilead Sciences Pty Ltd (2)
- GlaxoSmithKline Australia Pty Ltd (2)
- Novo Nordisk Pharmaceuticals Pty Ltd (2)
- Pierre Fabre Australia Pty Ltd (2)
- Roche Products Pty Ltd (2)
- Sanofi-Aventis Australia Pty Ltd (2)
- AA-Med Pty Ltd (1)
- Acumen Dental Unit Trust (1)
- Alexion Pharmaceuticals Australasia Pty Ltd (1)
- Amivas Australia Pty Ltd (1)
- Astellas Pharma Australia Pty Ltd (1)
- Biogen Australia Pty Ltd (1)
- Boehringer Ingelheim Pty Ltd (1)
- Chiesi Australia Pty Ltd (1)
- Cipla Australia Pty Ltd (1)
- Dr Falk Pharma Australia Pty Ltd (1)
- Fresenius Medical Care Australia Pty Ltd (1)
- Freyr Australia Pty Ltd (1)
- Indivior Pty Ltd (1)
- Innocare Pharma Australia Pty Ltd (1)
- iNova Pharmaceuticals (Australia) Pty Ltd (1)
- Ipsen Pty Ltd (1)
- JACE Pharma Pty Ltd (1)
- LEO Pharma Pty Ltd (1)
- Moderna Australia Pty Ltd (1)
- Nexo Pharmaceuticals Pty Ltd (1)
- Norgine Pty Ltd (1)
- Phebra Pty Ltd (1)
- PTC THERAPEUTICS AUSTRALIA PTY LIMITED (1)
- Reach Pharmaceuticals Pty Ltd (1)
- Specialised Therapeutics Alim Pty Ltd (1)
- Swedish Orphan Biovitrum Pty Ltd (1)
- Vertex Pharmaceuticals Australia Pty Ltd (1)
Search
85 result(s) found, displaying 1 to 25
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May-2025Prescription medicine evaluationActive ingredient: diltiazem hydrochloride.
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May-2025Prescription medicine evaluationActive ingredient: budesonide.
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Apr-2025Prescription medicine evaluationActive ingredient: iptacopan.
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Apr-2025Prescription medicine evaluationActive ingredient: birch bark dry extract (84-95 per cent) triterpenes.
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Apr-2025Prescription medicine evaluationActive ingredient: obinutuzumab.
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Apr-2025Prescription medicine evaluationActive ingredient: imlunestrant tosilate.
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Apr-2025Prescription medicine evaluationActive ingredient: selumetinib sulfate.
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Apr-2025Prescription medicine evaluationActive ingredient: glecaprevir, pibrentasvir.
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Apr-2025Prescription medicine evaluationActive ingredient: Meningococcal polysaccharide Group Y, Meningococcal polysaccharide group A, Meningococcal polysaccharide group C, Meningococcal polysaccharide group W135.
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Apr-2025Prescription medicine evaluationActive ingredient: tafasitamab.
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Apr-2025Prescription medicine evaluationActive ingredient: Mepolizumab.
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Apr-2025Prescription medicine evaluationActive ingredient: dengue virus serotype 1, dengue virus serotype 3, dengue virus serotype 4.
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Apr-2025Prescription medicine evaluationActive ingredient: Semaglutide.
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Mar-2025Prescription medicine evaluationActive ingredient: encorafenib.
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Mar-2025Prescription medicine evaluationActive ingredient: teduglutide.
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Mar-2025Prescription medicine evaluationActive ingredient: Orelabrutinib.
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Mar-2025Prescription medicine evaluationActive ingredient: pirtobrutinib.
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Mar-2025Prescription medicine evaluationActive ingredient: finerenone.
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Mar-2025Prescription medicine evaluationActive ingredient: binimetinib.
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Mar-2025Prescription medicine evaluationActive ingredient: tretinoin.
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Mar-2025Prescription medicine evaluationActive ingredient: sodium oxybate.
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Mar-2025Prescription medicine evaluationActive ingredient: clesrovimab.
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Mar-2025Prescription medicine evaluationActive ingredient: loncastuximab tesirine.
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Feb-2025Prescription medicine evaluationActive ingredient: pembrolizumab.
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Feb-2025Prescription medicine evaluationActive ingredient: tirzepatide.
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