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 | ||||||||||
MAH, country: | Synektik S.A., , Poland | ||||||||||
Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
ATC: |
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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 |