en

PRODUCT DETAIL

Beriate 500 IU

Code 26821
MA number 16/0147/15-S
Product Form: plv iio 1x500 IU+1x5 ml solv.(liek.inj.skl.+liek.inj.skl.+aplikačná súprava)
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
B02BD02 Coagulation factor VIII
Shelf life: 36
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: 22.04.2015
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Beriate_250_500_1000_2000 IU_04.2020.doc  
PIL: PIL_Beriate_250_500_1000_2000 IU_10.2020.doc  
Safety feature Yes
Data update: 17.01.2018
eu-flag.png sk-flag.png