Compassionate use of a medicinal product

Making a medicinal product available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product (the medicinal product concerned must either be subject of an application for a central marketing authorisation or must be undergoing clinical trials) [REG (EC) No 726/2004 Art 83(2)].