Code | 6782B | ||||||||||
MA number | 48/0090/21-S | ||||||||||
Product Form: | sol iru 1x5 ml (striek.inj.napl.plast.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Bayer AG, Germany | ||||||||||
Therapeutic Class: | 48 - DIAGNOSTICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 30.03.2021 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Gadovist 1,0 mmol_ml_10.2022.pdf |
SPC: | SPC_Gadovist 1,0 mmol_ml_10.2022.pdf |
Safety feature | No |
Data update: | 15.10.2021 |