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PRODUCT DETAIL

OBIZUR 500 U prášok a rozpúšťadlo na injekčný roztok

Code 6834B
MA number EU/1/15/1035/001
Product Form: plv iol 1x500 U (liek.inj.skl.)
MA Status: Ev - Valid centralised marketing authorisation under exceptional circumstances
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
B02BD14 Susoctocog alfa
Shelf life: 30
Container: glass vial
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: 11.11.2015
Validity: 13.11.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 06.05.2022
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