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PRODUCT DETAIL

BeneFIX 3000 IU prášok a rozpúšťadlo na injekčný roztok

Code 2555A
MA number EU/1/97/047/008
Product Form: plv iol 1x3000 IU+1x5 ml solv.(liek.inj.skl.+striek.napl.skl.+set inj.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B02 ANTIHEMORRHAGICS
B02B LOCAL HEMOSTATICS, COMBINATIONS
B02BD Blood coagulation factors
B02BD04 Coagulation factor IX
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
MA issued: 23.08.2012
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 12.07.2018
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