| Code | 6799B | ||||||||||
| MA number | 48/0090/21-S | ||||||||||
| Product Form: | sol iru 5x7,5 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 |
