Code | 12480 | ||||||||
MA number | 87/0229/00-S | ||||||||
Product Form: | sol pnd 8x2000 ml (dvojvak+luer konektor) | ||||||||
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 | ||||||||
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: | 28.06.2000 |
Pediatric warnings: | Yes |
Dokument: | Baxter DHPC_FINAL_FINAL_clean 20 12 2010_signed.pdf |
Dokument: | Baxter PD sol Endotoxin_AE reporting form active surveil.pdf |
Dokument: | Extraneal_Karta pacienta.pdf |
Dokument: | Extraneal_Upozornenie pre zdravotníckych pracovníkov.pdf |
Dokument: | Extraneal_Zoznam glukometrov používaných v danej krajine.pdf |
PIL: | PIL_EXTRANEAL_09.2024.pdf |
SPC: | SPC_EXTRANEAL_09.2024.pdf |
Safety feature | Yes |
Data update: | 01.02.2022 |