Code | 80305 | ||||||||||
MA number | 76/0677/08-S | ||||||||||
Product Form: | emu inf 4x1448 ml (vak Biofin) | ||||||||||
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: |
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Shelf life: | 24 | ||||||||||
Container: | bag | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 23.12.2008 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_SmofKabiven Peripheral_08.2023.pdf |
SPC: | SPC_SmofKabiven Peripheral_08.2023.pdf |
Safety feature | No |
Data update: | 26.09.2019 |