What is an “unlicensed” medicine?
An unlicensed medicine can be:
A medicine that has a license but needs to be made in a different, unlicensed formulation (e.g. oral medication made into a liquid formulation or a different strength of medication to the licensed version)
A medicine that has a license in other countries, but not the UK
A medicine that has no license at all
What is an “off-label” medicine?
An off-label medicine is one that is used in a different way to that described in its licence. Examples of off-label use include:
Using a medicine for a different condition to that stated in the licence. This may happen because doctors have found that the medicine works very well for another condition. Using the medicine in this way may be supported by expert groups, but the manufacturer of the medication has not extended its licence.
Using a medicine in an age group beyond the boundaries of the licenced range.
Using a medicine at a higher dose than stated in the licence.
All requests for our unlicensed and off-label medicines are reviewed by our clinicians. The clinician will review the clinical presentation and only prescribe the medicine if it is clinically appropriate, based on individual circumstances.