Code | 8499A | ||||||||||
MA number | 48/0501/13-S | ||||||||||
Product Form: | sol inj 1x20 ml (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Guerbet, France | ||||||||||
Therapeutic Class: | 48 - DIAGNOSTICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 03.01.2014 |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Dotarem_sol inj_unidose_08.2024.pdf |
SPC: | SPC_Dotarem_sol inj_Unidose_08.2024.pdf |
Safety feature | No |
Data update: | 19.03.2018 |