Medicinal product name Axumin
Pharmaceutical form Solution for injection
Strength 3200 MBq/ml 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.II stac.)
Summary of product characteristics, package leaflet and labeling text  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code V09IX12 Diagnostic radiopharmaceuticals

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N1
(3200 MBq/ml)
Glass vial    EU/1/17/1186/002  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/17/1186/002
Date of authorisation May 22, 2017
Marketing authorisation holder, country Blue Earth Diagnostics Ireland Ltd, Ireland