| Code | 08335 | ||||||||
| MA number | 87/0114/00-S | ||||||||
| Product Form: | sol pnd 6x1500 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: |
|
||||||||
| 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 |
