Navigation and service

You are here:Homepage

Compassionate Use

"Compassionate use" refers to the use of medicinal products that are not yet authorised or licensed. A case for compassionate use exists when a group of patients suffering from a disease which would lead to serious disability or is life-threatening cannot be satisfactorily treated with an authorised or licensed medicinal product.
Within a compassionate use programme, medicinal products can be made available to patients if sufficient indications of the efficacy and safety of the medicinal product exist. Furthermore, either a clinical trial of the product must be ongoing or an application for marketing authorisation must have been submitted to the European Medicines Agency, the BfArM, or another licensing authority of a European Member State.