Glossary

off-label use

Off-label use is non-approved use, which means that a drug is used for an illness or disease for which it has not been licensed by the country’s medicine authorities – for example, a drug that has been tested and licensed for treating people with blood cancer is also used for treating people with stomach cancer. When a doctor prescribes a drug off-label, the question arises of who is liable for possible adverse effects. Usually, liability lies with the manufacturer of the medication. Patients need to be informed about possible consequences. In Germany, health insurances cover the costs for an off-label use of a drug only in exceptional cases. Find out more: What is “off-label use”?