Axumin (fluciclovine (18F))
- Region
- 🇪🇺 EU
- Active substance
- fluciclovine (18F)
- Company
- Blue Earth Diagnostics Ireland Ltd
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms; Radionuclide Imaging
- CHMP opinion
- Wed 22 Mar 2017
- EU approval
- Sun 21 May 2017
- Application
- EMEA/H/C/004197
- ATC
- V09IX12
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.