Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorisation.

Examples include the intentional use of a product in situations other than the ones described in the authorised product information, such as a different indication in terms of medical condition, a different group of patients (e.g. a different age group), a different route or method of administration or a different posology. The reference terms for off-label use are the terms of marketing authorisation in the country where the product is used.