Medicines Healthcare Products Regulatory Agency
Coronary heart disease (CHD) is a major cause of death worldwide, responsible for 68,000 deaths in the UK each year.
CHD occurs when blood supply to the heart is blocked by a build-up of fatty material in the coronary arteries, which could in some cases lead to a heart attack.
With 2.3 million people living with the disease, CHD is the most common form of heart and circulatory disease in the UK.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
Were assured that the appropriate regulatory standards for the approval of this diagnostic have been met.
As with all products, we will keep its safety under close review.
The Rubidium (Rb82) Generator involves one or two injections under supervision of a specialist doctor, at least 10 minutes apart, with scans taking place within 5 minutes each time.
This radiopharmaceutical substance contains a small amount of radioactivity and temporarily collects in certain parts of the body, which can be detected from outside of the body with special cameras. A healthcare professional will then take an image which can provide valuable information about blood flow to the heart.
This radiopharmaceutical will deliver low amounts of ionizing radiation, which is associated with a very low risk of cancer and hereditary abnormalities (passing on faulty genes). The doctor will have considered that the clinical benefit obtained from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
As with any medicine, the MHRA will keep the safety and effectiveness of the Rubidium (Rb82) Generator under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors?
- The new marketing authorisation was granted on 6 March 2024 to Jubilant Pharmaceuticals N.V.
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- For more information about the study, see the Summary of Product Characteristics.
- For more information about coronary heart disease, visit: https://www.nhs.uk/conditions/coronary-heart-disease/
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or cal