en

PRODUCT DETAIL

Beriplex 500 IU

Code 9377B
MA number 16/0250/16-S
Product Form: plv iol 1x500 IU+1x20 ml solv (liek.inj.skl.+liek.inj.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B02 ANTIHEMORRHAGICS
B02B LOCAL HEMOSTATICS, COMBINATIONS
B02BD Blood coagulation factors
B02BD01 Coagulation factor IX, II, VII and X in combinatio
Shelf life: 36
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 19.05.2016
Pediatric posology: Yes
PIL: PIL Beriplex 500 IU_11.2017.doc  
SPC: SPC_Beriplex 500 IU_ 1000 IU_07.2021.pdf  
Safety feature Yes
Data update: 16.04.2018
eu-flag.png sk-flag.png