Code | 4398E | ||||||||||
MA number | 16/0214/23-S | ||||||||||
Product Form: | plv fol 1x1000 U+20 ml solv.(liek.inj.skl.+prísl.) | ||||||||||
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 |