This is a summary of the European public assessment report (EPAR) for Axumin. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Axumin. For practical information about using Axumin, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication 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.
Therapeutic Area (MeSH)
ATC Code
V09IX12
ATC Item
fluciclovine (18F)
Pharmacotherapeutic Group
Diagnostic radiopharmaceuticals
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| fluciclovine (18F) | N/A | Fluciclovine (18F) |
| Fluciclovine (18F) | N/A | Fluciclovine (18F) |
EMA Name
Axumin
Medicine Name
Axumin
Aliases
N/A