Coronary heart disease (CHD) is the leading cause of death around the world, killing 68,000 people in the UK each year.

CHD occurs when a buildup of fatty material in the coronary arteries blocks the blood supply to the heart, which in some cases can 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 Beech, interim executive director for quality and access at the MHRA, said:

Ensuring patient safety and access to high-quality, safe and effective medical products are important priorities for our company.

We ensure that the appropriate regulatory standards required for approval of this diagnosis are met.

As with all of our products, we maintain their safety under close scrutiny.

With the Rubidium (Rb82) generator, one or two injections are given at least 10 minutes apart, under the supervision of a specialist doctor, and scans are taken within 5 minutes each time.

This radiopharmaceutical substance contains trace amounts of radioactivity that temporarily collects in certain parts of the body and can be detected from outside the body with a special camera. Medical professionals take images that can provide valuable information about blood flow to the heart.

This radiopharmaceutical emits small amounts of ionizing radiation with a very low risk of cancer or genetic abnormalities (transmission of defective genes). Physicians may believe that the clinical benefits of radiopharmaceutical treatment outweigh the radiation risks.

As with other medicines, the MHRA keeps the safety and effectiveness of rubidium (Rb82) generators under close scrutiny. If you suspect any side effects from this medicine, we recommend that you speak to your doctor, pharmacist or nurse and report them directly to the MHRA Yellow Card Scheme through the website https://yellowcard.mhra.gov.uk. Recommended. /) Or search for MHRA Yellow Card on Google Play Store or Apple App Store.

Note to editor

1. The new marketing authorization was granted to Jubilant Pharmaceuticals NV on March 6, 2024.
2. For more information, please see the Summary of Product Characteristics and Patient Information leaflet, which will be published on the MHRA product website within 7 days of approval.
3. For more information about the study, see Overview of Product Characteristics.
4. For more information about coronary heart disease, visit https://www.nhs.uk/conditions/coronary-heart-disease/.
5. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring that they work and are reasonably safe. All of our work is backed by solid fact-based judgment to ensure the benefits are worth the risks.
6. The MHRA is the executive arm of the Department of Health and Social Care.
7. For media inquiries please contact newscentre@mhra.gov.uk or call 020 3080 7651.