| Code | 2846F | ||||||||||
| MA number | 76/0041/26-S | ||||||||||
| Product Form: | emu inf 4x1500 ml (vak Biofine) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| 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: | 27.02.2026 |
| Validity: | 27.02.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Pedismof Pediatric_02_2026.pdf
|
| SPC: |
SPC_Pedismof Pediatric_02_2026.pdf
|
| Safety feature | No |
| Data update: | 04.03.2026 |
