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PRODUCT DETAIL

CEVENFACTA 5 mg (225 KIU) prášok a rozpúšťadlo na injekčný roztok

Code 2001E
MA number EU/1/22/1664/003
Product Form: plv iol 1x5 mg + 5,2 ml solv.(liek.skl. + striek.inj.napl.)
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
B02BD08 Eptacog alfa (activated)
Shelf life: 36
Container: glass container
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 15.07.2022
Validity: 15.07.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 07.09.2022
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