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Prescription medicines under evaluation
These applications for new medicines or new uses for existing medicines are currently under evaluation by the TGA. Evaluation does not guarantee registration or 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.
Use the filters below to narrow your search.
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You can narrow down the results using the filters.
Application type
Sponsor
- AstraZeneca Pty Ltd (14)
- Merck Sharp & Dohme (Australia) Pty Ltd (7)
- Bristol-Myers Squibb Australia Pty Ltd (6)
- Janssen-Cilag Pty Ltd (6)
- Accelagen Pty Ltd (4)
- Amgen Australia Pty Ltd (4)
- Astellas Pharma Australia Pty Ltd (4)
- Eli Lilly Australia Pty Ltd (4)
- GlaxoSmithKline Australia Pty Ltd (4)
- Seqirus Pty Ltd (4)
- AbbVie Pty Ltd (3)
- AFT Pharmaceuticals Pty Ltd (3)
- BeiGene AUS Pty Ltd (3)
- Ipsen Pty Ltd (3)
- Novartis Pharmaceuticals Australia Pty Ltd (3)
- Novo Nordisk Pharmaceuticals Pty Ltd (3)
- Roche Products Pty Ltd (3)
- Vertex Pharmaceuticals Australia Pty Ltd (3)
- Amicus Therapeutics Pty Ltd (2)
- Chiesi Australia Pty Ltd (2)
- Pfizer Australia Pty Ltd (2)
- Specialised Therapeutics Pharma Pty Ltd (2)
- UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia (2)
- AA-Med Pty Ltd (1)
- Actor Pharmaceuticals Pty Ltd (1)
- Acumen Dental Unit Trust (1)
- A Menarini Australia Pty Ltd (1)
- Amivas Australia Pty Ltd (1)
- Apellis Australia Pty Ltd (1)
- Arctic Vision Australia Pty Ltd (1)
- Argenx Australia Pty Ltd (1)
- Ballia Holdings Pty Ltd (1)
- Bayer Australia Ltd (1)
- Biogen Australia Pty Ltd (1)
- Boehringer Ingelheim Pty Ltd (1)
- Celgene Pty Ltd (1)
- Cipla Australia Pty Ltd (1)
- CSL Behring Australia Pty Ltd (1)
- Fresenius Medical Care Australia Pty Ltd (1)
- Freyr Australia Pty Ltd (1)
- Galderma Australia Pty Ltd (1)
- Gilead Sciences Pty Ltd (1)
- Guerbet Australia Pty Ltd (1)
- JACE Pharma Pty Ltd (1)
- Jazz Pharmaceuticals ANZ Pty Ltd (1)
- Link Medical Products Pty Ltd T/A Link Pharmaceuticals (1)
- Merz 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)
- Revance Australia Pty Ltd (1)
- Sanofi-Aventis Australia Pty Ltd (1)
- Sun Pharma ANZ Pty Ltd (1)
- Swedish Orphan Biovitrum Pty Ltd (1)
- Taiho Pharma Oceania Pty Ltd (1)
- Takeda Pharmaceuticals Australia Pty Ltd (1)
Accepted date
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126 result(s) found, displaying 1 to 25
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Nov-2024Prescription medicine evaluationActive ingredient: cabozantinib (S)-malate.
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Nov-2024Prescription medicine evaluationActive ingredient: selpercatinib.
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Oct-2024Prescription medicine evaluationActive ingredient: Diphtheria toxoid, Pertactin, Pertussis filamentous haemagglutinin, Pertussis toxoid, Poliovirus, Tetanus toxoid.
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Oct-2024Prescription medicine evaluationActive ingredient: Sebetralstat.
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Oct-2024Prescription medicine evaluationActive ingredient: nivolumab.
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Oct-2024Prescription medicine evaluationActive ingredient: landiolol hydrochloride.
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Sep-2024Prescription medicine evaluationActive ingredient: bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate.
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Sep-2024Prescription medicine evaluationActive ingredient: glofitamab.
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Sep-2024Prescription medicine evaluationActive ingredient: trastuzumab deruxtecan.
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Sep-2024Prescription medicine evaluationActive ingredient: ropinirole hydrochloride.
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Sep-2024Prescription medicine evaluationActive ingredient: sipavibart.
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Sep-2024Prescription medicine evaluationActive ingredient: Liraglutide.
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Sep-2024Prescription medicine evaluationActive ingredient: lutetium (177Lu) oxodotreotide.
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Sep-2024Prescription medicine evaluationActive ingredient: tirzepatide.
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Sep-2024Prescription medicine evaluationActive ingredient: Semaglutide.
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Sep-2024Prescription medicine evaluationActive ingredient: Bibrocathol.
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Sep-2024Prescription medicine evaluationActive ingredient: deutivacaftor, tezacaftor, vanzacaftor.
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Sep-2024Prescription medicine evaluationActive ingredient: Ipilimumab.
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Sep-2024Prescription medicine evaluationActive ingredient: lidocaine hydrochloride.
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Aug-2024Prescription medicine evaluationActive ingredient: Artesunate.
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Aug-2024Prescription medicine evaluationActive ingredient: durvalumab.
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Aug-2024Prescription medicine evaluationActive ingredient: mirikizumab.
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Aug-2024Prescription medicine evaluationActive ingredient: guselkumab.
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Jul-2024Prescription medicine evaluationActive ingredient: oxybutynin hydrochloride.
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