What is unlicensed medication?

Unlicensed medication, also referred to as off-label or off-licence, is medication that is prescribed for a use other than the use listed in the terms of its licence, within the country of use.

The licence says what conditions the medication can be used for, what age patients it can be given to, how much can be given and how to give it. However, there are many medications that are used either outside of the terms of their licences or without a licence at all, when it is in the patient’s best interests.

One common example is the group of medicines called oral contraceptives. These are licensed for use as contraceptives, but some of them have been effective in a much wider range of applications, including the treatment of period pain and endometriosis.

Full information about unlicensed medication can be found on our website.