Code | 2199D | ||||||||||
MA number | 57/0331/18-S | ||||||||||
Product Form: | sol ijf 10x10 ml ml (amp.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | AS KALCEKS, Latvia | ||||||||||
Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Container: | glass ampoule | ||||||||||
Route of admin.: | Intravenous, intramuscular, rectal use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 11.10.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Midazolam Kalceks_injekčný_infúzny roztok_10.2023.pdf |
SPC: | SPC_Midazolam Kalceks_injekčný_infúzny roztok_11.2023.pdf |
Safety feature | Yes |
Data update: | 27.03.2023 |