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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.

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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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