| Code | 47749 | ||||||||
| MA number | 75/0190/16-S | ||||||||
| Product Form: | sol inf 1x200 ml (vak PVC) | ||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||
| MAH, country: | Octapharma (IP) SPRL, Belgium | ||||||||
| Therapeutic Class: | 75 - SUBSTITUTIO SANGUINIS (A KRVNÉ DERIVÁTY) | ||||||||
| ATC: |
|
||||||||
| Shelf life: | 48 | ||||||||
| Container: | bag PVC | ||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 30.05.2016 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Octaplasma_02.2025.pdf
|
| PIL: |
PIL_Octaplasma_02.2025.pdf
|
| Safety feature | Yes |
| Data update: | 11.02.2021 |
