The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending that regadenoson (Rapiscan®) 400 mg solution for injection be granted a marketing authorisation in the EU for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging in adult patients unable to undergo adequate exercise stress.

The positive opinion notes that the benefits with regadenoson are its ability to selectively increase coronary blood flow, while minimising some of the side effects caused by the currently approved pharmacologic stress agents. The most common side effects are dyspnoea, headache, flushing, chest pain, electrocardiogram ST segment changes, gastrointestinal discomfort and dizziness. A pharmacovigilance plan for the agent will be implemented as part of the marketing authorisation. Treatment with Rapiscan is restricted to use in a medical facility where cardiac monitoring and resuscitation equipment are available.