Code | 76909 | ||||||||||
MA number | 57/0347/09-S | ||||||||||
Product Form: | sol ijf 1x10 ml/50 mg (amp.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Accord Healthcare Polska Sp. z o.o., Poland | ||||||||||
Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 48 | ||||||||||
Container: | glass ampoule | ||||||||||
Route of admin.: | Intravenous, intramuscular, rectal use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 18.06.2009 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Midazolam Accord 5 mg/ml_sol ijf_02_2024.pdf |
PIL: | PIL_Midazolam Accord_sol ijf_02_2024.pdf |
Safety feature | Yes |
Data update: | 29.03.2018 |