Code | 08336 | ||||||||
MA number | 87/0114/00-S | ||||||||
Product Form: | sol pnd 5x2000 ml (dvojvak PVC) | ||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
Type of procedure: | National | ||||||||
MAH, country: | Vantive Belgium SRL, Belgium | ||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||
ATC: |
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Shelf life: | 24 (12) | ||||||||
Container: | bag PVC | ||||||||
Route of admin.: | Intraperitoneal use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 13.04.2000 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Dokument: | Baxter DHPC_FINAL_FINAL_clean 20 12 2010_signed.pdf |
Dokument: | Baxter PD sol Endotoxin_AE reporting form active surveil.pdf |
PIL: | PIL_Dianeal PD4 Glucose_09.2024.pdf |
SPC: | SPC_Dianeal PD4 Glucose_09.2024.pdf |
Safety feature | Yes |
Data update: | 28.05.2018 |