To identify the medicine as the an advanced therapy medicinal product, the package leaflet should include the following information:

  1. the name of the advanced therapy medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults. The common name shall be included;
  2. the therapeutic group or type of activity in terms easily understandable for the patient;
  3. where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin;
  4. where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin.