Code | 4680C | ||||||||||
MA number | EU/1/17/1186/002 | ||||||||||
Product Form: | sol inj 1x1,0 - 10 ml/3200 - 32 000 MBq (liek.inj.skl.-10 ml) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Blue Earth Diagnostics Ireland Ltd, Ireland | ||||||||||
Therapeutic Class: | 88 - RADIOPHARMACA | ||||||||||
ATC: |
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Shelf life: | 10 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 |