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PRODUCT DETAIL

Gadovist 1,0 mmol/ ml

Code 6801B
MA number 48/0090/21-S
Product Form: sol iru 5x10 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:
V VARIOUS
V08 CONTRAST MEDIA
V08C MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
V08CA Paramagnetic contrast media
V08CA09 Gadobutrol
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
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