| Code | 9171D | ||||||||||
| MA number | 57/0268/21-S | ||||||||||
| Product Form: | sol ijf 10x5 ml/5 mg (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AS KALCEKS, Latvia | ||||||||||
| 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 restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 04.01.2022 |
| Validity: | 04.01.2027 |
| MA renewed: | Renewal application submitted |
| 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: | 24.11.2023 |
