What does "off-label" mean?
A single medicine can sometimes be used for different conditions or in different groups of people, for example in both children and adults. The use of that medicine first has to be approved separately for each indication and each group of people, though. Pharmaceutical companies apply to the regulatory authorities for such approval of use. But they are under no obligation to apply for the same kind of approval for a product in all countries. This means that a particular medicine might be licensed for a particular indication in one country (country A), but not in another (country B). If a person in country B is prescribed that medicine for that purpose anyway, then they are using the medicine off-label.
Prescribing a medicine off-label is associated with particular risks for doctors. They might face liability problems if there are serious side effects. For this reason, doctors' associations recommend only considering if current guidelines, recommendations or recognized scientific literature provide supporting such use.
If a patient is receiving a medicine off-label, she or he needs to be informed that the use is off-label, and told about the possible consequences. It is important for patients to know that there may not be enough research on the benefits and harms of the medicine when used for that off-label purpose. Also, the statutory health insurance funds in Germany only rarely cover the costs of medicines that are used off-label.