| Code | 3100F | ||||||||||
| MA number | 48/0108/26-S | ||||||||||
| Product Form: | sol iru 5x7,5 ml/4 535,4 mg (striek.inj.napl.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Farmak International Sp. z o.o., Poland | ||||||||||
| 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 10(1) generic application |
| MA issued: | 11.04.2026 |
| Validity: | 11.04.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Gadobutrol FMK 1 mmol/ml injekčný roztok v naplnenej injekčnej striekačke_03.2026.pdf
|
| SPC: |
SPC_Gadobutrol FMK 1 mmol/ml injekčný roztok v naplnenej injekčnej striekačke_03.2026.pdf
|
| Safety feature | No |
| Data update: | 13.04.2026 |
