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PRODUCT DETAIL

Midazolam hameln 1 mg/ml injekčný/infúzny roztok

Code 8047D
MA number 57/0196/21-S
Product Form: sol ijf 1x50 ml (liek.inj.skl.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
Therapeutic Class: 57 - HYPNOTICA, SEDATIVA
ATC:
N NERVOUS SYSTEM
N05 PSYCHOLEPTICS
N05C HYPNOTICS AND SEDATIVES
N05CD Benzodiazepine derivatives
N05CD08 Midazolam
Shelf life: 36
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: 30.07.2021
Validity: 30.07.2026
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Midazolam hameln_sol ifj_02_2024.pdf  
PIL: PIL_Midazolam hameln_sol ifj_02_2024.pdf  
Safety feature Yes
Data update: 02.08.2021
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