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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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