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PRODUCT DETAIL

FLUOROCHOLINE (18F) SYNEKTIK 1 GBq/ml injekčný roztok

Code 8265C
MA number 88/0159/18-S
Product Form: sol inj 1x0,5-15 ml/500-15000 MBg (15 ml liek.inj.skl.viacdáv.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 88 - RADIOPHARMACA
ATC:
V VARIOUS
V09 DIAGNOSTIC RADIOPHARMACEUTICALS
V09I TUMOUR DETECTION
V09IX Other diagnostic radiopharmaceuticals for tumour diagnostic
V09IX07 Fluoromethylcholine (18F)
Shelf life: 14 hodín
Container: multidose glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10a well-established use application
MA issued: 13.06.2018
PIL: PIL_FLUOROCHOLINE (18F) SYNEKTIK_09.2022.pdf  
SPC: SPC_FLUOROCHOLINE (18F) SYNEKTIK_09.2022.pdf  
Safety feature No
Data update: 18.11.2022
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