Code | 81312 | ||||||||||
MA number | 76/0622/09-S | ||||||||||
Product Form: | sol inf 20x500 ml (vak freeflex) | ||||||||||
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: | 36 | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 26.10.2009 |
Pediatric posology: | Yes |
SPC: | SPC_Isolyte_08.2019.doc |
PIL: | PIL_Isolyte_05.2020.doc |
Safety feature | No |
Data update: | 13.08.2019 |