| Code | 4342D | ||||||||||
| MA number | 76/0093/20-S | ||||||||||
| Product Form: | sol inf 1x2000 ml (vak dvojkomor.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 76 - INFUNDIBILIA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | bag | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 29.04.2020 |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| PIL: |
|
| SPC: |
|
| Safety feature | No |
| Data update: | 23.06.2025 |