| Code | 76907 | ||||||||||
| MA number | 57/0347/09-S | ||||||||||
| Product Form: | sol ijf 10x1 ml/5 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: |
|
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| 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_12_2024.pdf
|
| PIL: |
PIL_Midazolam_Accord sol ijf_08_2025.pdf
|
| Safety feature | Yes |
| Data update: | 29.03.2018 |
