| Code | 4339D | ||||||||||
| MA number | 76/0093/20-S | ||||||||||
| Product Form: | sol inf 6x1000 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 |