| Code | 9416E | ||||||||||
| MA number | 63/0104/25-S | ||||||||||
| Product Form: | sol ijf 10x5 ml/50 mg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Noridem Enterprises Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 63 - MYORELAXANTIA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.03.2025 |
| Validity: | 28.03.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Rocuronium bromide Noridem 10 mg/ml injekčný/infúzny roztok_,03_2025.pdf
|
| SPC: |
SPC_Rocuronium bromide Noridem 10 mg/ml injekčný/infúzny roztok_03_2025.pdf
|
| Safety feature | Yes |
| Data update: | 31.03.2025 |
