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What is an unlicensed or off-label medication?

Last updated on Mar 30, 2026

What is an "unlicensed" medicine?

An unlicensed medicine is one that does not hold a full marketing authorisation in the UK. This can mean:

  • A medicine that has a licence elsewhere but not currently in the UK.
  • A medicine that has a licence for a particular form but needs to be prepared in a different formulation.
  • A medicine with no licence anywhere.

What is an "off-label" medicine?

An off-label medicine is one that is licensed but being used in a way that falls outside the scope of its original licence. Common examples include:

  • Prescribing a medicine for a condition not stated in its licence — where clinical evidence supports the use.
  • Using a medicine in an age group outside the licensed range.
  • Using a medicine at a dose higher than the licensed maximum.

All requests for unlicensed and off-label medicines at Evernu are reviewed individually by a clinician. The clinician will only prescribe if the treatment is clinically appropriate for your specific circumstances.