Code | 01571 | ||||||||||
MA number | 16/0225/13-S | ||||||||||
Product Form: | plv iio 1x1000 U+20 ml solv.(liek.inj.skl.+prísl.+Baxject II Hi-Flow) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
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 medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 30.12.1980 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
SPC: | SPC_FEIBA 50 U_ml_plv inj_12.2020.doc |
PIL: | PIL_FEIBA 25 Uml_50 Uml_05.2022.pdf |
Safety feature | Yes |
Data update: | 19.05.2020 |