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PRODUCT DETAIL

Axumin 1 600 MBq/ml injekčný roztok

Code 0539D
MA number EU/1/17/1186/003
Product Form: sol inj 1x1,0 - 10 ml/1600 - 16 000 MBq (liek.inj.skl.-15 ml)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 88 - RADIOPHARMACA
ATC:
V VARIOUS
V09 DIAGNOSTIC RADIOPHARMACEUTICALS
V09I TUMOUR DETECTION
V09IX Other diagnostic radiopharmaceuticals for tumour diagnostic
V09IX12 Fluciclovine (18F)
Shelf life: 8 hodín
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 22.05.2017
SmPC + PL: European Medicines Agency's database
Safety feature No
Data update: 02.03.2022
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