“Off-label use”: What to be aware of
Off-label use means “non-approved use.” In other words, it is the use of a medicine in an indication for which it has not been licensed by the country's regulatory authorities.
Every medicine that you can buy from a pharmacy or drugstore in Europe needs to have been assessed and licensed by a regulatory authority. The responsible authority in Germany is the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). The European licensing authority is based in London and is called the European Medicines Agency (EMA), and its counterpart in the United States is called the Food and Drug Administration (FDA).
Please note that the information below reflects the situation in Germany and may not apply to other countries.