Code | 0509D | ||||||||||
MA number | 63/0041/19-S | ||||||||||
Product Form: | sol ijf 10x5 ml/50 mg (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | AS KALCEKS, Latvia | ||||||||||
Therapeutic Class: | 63 - MYORELAXANTIA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 11.02.2019 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_Rocuronium bromide Kalceks 10 mg_ml injekčný_infúzny roztok_10_2023.pdf |
SPC: | SPC_Rocuronium bromide Kalceks 10 mg_ml injekčný_infúzny roztok_10_2023.pdf |
Safety feature | Yes |
Data update: | 02.08.2023 |