Active substance
This medicinal product is for diagnostic use only. Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| AXUMIN 1600 MBQ/ML SOLUTION FOR INJECTION | PLGB 44578/0001 | BLUE EARTH DIAGNOSTICS LIMITED | POM |
| AXUMIN 3200 MBQ/ML SOLUTION FOR INJECTION | PLGB 44578/0002 | BLUE EARTH DIAGNOSTICS LIMITED | POM |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.