What does “off-label” or unlicensed medication mean?

What is an unlicensed medicine?

An unlicensed medicine is a medicine that does not hold a UK licence in its prescribed form. This may include:

• A medicine that is licensed, but supplied in a different formulation or strength than the licensed version

• A medicine that is licensed in other countries but not currently licensed in the UK

• A medicine that does not yet have a licence

What is an off-label medicine?

An off-label medicine is a licensed medicine that is prescribed in a way that differs from its approved licence. This can include:

• Use for a condition not specifically listed in the licence

• Use in an age group outside the licensed range

• Use at a different dose than stated in the licence

Off-label use is common in clinical practice and is often supported by medical evidence and professional guidelines, even if the manufacturer has not updated the licence.

How prescribing decisions are made

All requests for unlicensed or off-label medicines are carefully reviewed by an independent clinician. Prescriptions are only issued when the clinician determines the treatment is clinically appropriate, safe, and suitable based on your individual circumstances.