“Off-label use”: What to be aware of
Off-label use means “non-approved use.” In other words, it is when a medicine is used in a group of people or for a certain medical condition although this type of use hasn’t been approved by the country's regulatory authorities. For instance, a doctor may prescribe a certain medicine for a child although that medicine has only been approved for use in adults.
Every medicine that you can buy from a pharmacy in Europe needs to have been assessed and licensed by a regulatory authority. The European licensing authority is called the European Medicines Agency (EMA). The responsible authorities in Germany are the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and – for some medications, like vaccines – the Paul Ehrlich Institute (PEI).