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PRODUCT DETAIL

FEIBA 100 U/ml prášok a rozpúšťadlo na infúzny roztok

Code 6172E
MA number 16/0109/24-S
Product Form: plv fol 1x500 U+5 ml solv. (liek.inj.skl.+prísl.+Baxject II Hi-Flow)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Baxalta Innovations GmbH, Austria
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B02 ANTIHEMORRHAGICS
B02B LOCAL HEMOSTATICS, COMBINATIONS
B02BD Blood coagulation factors
B02BD03 Factor VIII inhibitor bypassing activity
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: 10.05.2024
Validity: 10.05.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_FEIBA 100 U ml_05.2024.pdf  
SPC: SPC_FEIBA 100 U ml_05.2024.pdf  
Safety feature Yes
Data update: 13.05.2024
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