EMA approves a new generic for the diagnosis of dementia with Lewy bodies

10/08/2021

The European Medicines Agency (EMA) has approved the medicine Celsunax to help in the diagnosis of movement disorders and dementia (loss of intellectual function). Celsunax is used to help distinguish between dementia with Lewy bodies and Alzheimer’s disease. This medicine is a generic version of DaTSCAN. Both Celsunax and DaTSCAN contain the same active radiopharmaceutical substance ioflupane.

Celsunax can only be obtained with a prescription and should only be used in people who have been referred by a doctor with experience in the management of movement disorders or dementia. The EMA concluded that, in accordance with EU requirements, Celsunax has been shown to be comparable to DaTSCAN. Therefore, the Agency’s view was that, as for DaTSCAN, the benefits of Celsunax outweigh the identified risks and it can be authorised for use in the European Union. For further information please see the page entitled “Celsunax” on the EMA website at: https://www.ema.europa.eu/en/medicines/human/EPAR/celsunax