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PRODUCT DETAIL

FACTOR VII NF Baxalta

Code 90099
MA number 16/0118/81-CS
Product Form: plv iol 1x600 IU+1x10 ml solv. (liek.skl.+liek.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B02 ANTIHEMORRHAGICS
B02B LOCAL HEMOSTATICS, COMBINATIONS
B02BD Blood coagulation factors
B02BD05 Coagulation factor VII
Shelf life: 36
Container: glass container
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 30.03.1981
Dokument: DHPC Factor VII 9 11 2015 Baxter.pdf  
SPC: SPC_FACTOR VII NF Baxalta_04.2021.pdf  
PIL: PIL_FACTOR VII NF Baxalta_05.2022.pdf  
Safety feature Yes
Data update: 20.02.2018
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