What is “off-label use”?

“Off-label use” essentially means that a medicinal product is used in a way that is not covered by the official information on its use (i.e. the so-called Summary of Product Characteristics).
This means, for example, that it is used for a disease for which it was not originally approved, or in a dosage or age group that is not mentioned in the Summary of Product Characteristics.

There is no legally binding definition of this term in the Medicines Act.

Is off-label use permitted?

Yes – in principle, off-label use is not prohibited.

However, special requirements apply, namely:

• Even greater care must be taken than with the usual approved use.
• The patient must be specifically informed about the special use of the medicine.
• The responsibility for this lies with the treating doctors.
• The doctor must justify the medical and therapeutic necessity of off-label use in each individual case.
• In doing so, they must be guided by the current state of medicine and take into account the best available knowledge/scientific evidence.