| Code | 5095C | ||||||||||
| MA number | 75/0260/17-S | ||||||||||
| Product Form: | plv iio 1x1 g (fľ.skl.+pomôcka Nextaro) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Octapharma (IP) SPRL, Belgium | ||||||||||
| Therapeutic Class: | 75 - SUBSTITUTIO SANGUINIS (A KRVNÉ DERIVÁTY) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | glass bottle | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 12.09.2017 |
| SPC: |
SPC_Fibryga_04.2025.pdf
|
| PIL: |
PIL_Fibryga_04.2025.pdf
|
| Safety feature | Yes |
| Data update: | 14.03.2024 |
