Code | 84693 | ||||||||
MA number | 87/0674/09-S | ||||||||
Product Form: | sol hhh 2x5000 ml (250 ml+4750 ml) (vak polyolefín.) | ||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
Type of procedure: | Mutual recognition procedure | ||||||||
MAH, country: | Vantive Belgium SRL, Belgium | ||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||
ATC: |
|
||||||||
Shelf life: | 18 | ||||||||
Route of admin.: | Intravenous use and haemodialysis |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 15.12.2009 |
Pediatric posology: | Yes |
PIL: | PIL_Prismasol 4 mmol_l_polyolefin with valve_10.2024.pdf |
PIL: | PIL_Prismasol 4 mmol_l_pvc with pin_10.2024.pdf |
PIL: | PIL_Prismasol 4 mmol_l_pvc with valve_10.2024.pdf |
SPC: | SPC_Prismasol 4 mmol Draslík roztok na hemodialýzu_hemofiltráciu_10.2024.pdf |
Safety feature | Yes |
Data update: | 04.06.2020 |