“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 to treat a medical condition 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 main responsible authority in Germany is the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). The European licensing authority is called the European Medicines Agency (EMA). You will find detailed information about all of the situations for which the use of a medication has been approved in the "Indications and Usage" section of the accompanying package insert.
This includes both the specific medical problem to be treated and the group of people who can use it. Some medications have only been approved for certain forms of a disease and only in certain groups of people, such as women, men, children or adults.
One medication can sometimes be used for more than one medical condition or in different groups of people, for example in both children and adults. The manufacturer can apply for separate licenses for each combination of a medical condition and group of people (in other words, for each indication).
