| Code | 4399E | ||||||||||
| MA number | 16/0214/23-S | ||||||||||
| Product Form: | plv fol 1x1000 U+20 ml solv.(liek.inj.skl.+prísl.+Baxject II Hi-Flow) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| 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: | 25.09.2023 |
| Validity: | 25.09.2028 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_FEIBA 50 U_ml_09_2023.pdf
|
| SPC: |
SPC_FEIBA 50 U_ml_09_2023.pdf
|
| Safety feature | Yes |
| Data update: | 27.09.2023 |
