Code | 5291C | ||||||||||
MA number | 76/0285/17-S | ||||||||||
Product Form: | emu inf 4x1518 ml (vak Biofin) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
Therapeutic Class: | 76 - INFUNDIBILIA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bag Biofin | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 04.10.2017 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_SmofKabiven extra Nitrogen Electrolyte free_08.2023.pdf |
SPC: | SPC_SmofKabiven extra Nitrogen Electrolyte free_08.2023.pdf |
Safety feature | No |
Data update: | 14.07.2022 |