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PRODUCT DETAIL

OCTANINE F 500 I.U.

Code 14110
MA number 16/0244/10-S
Product Form: plv iol 1x500 IU+1x5 ml solv. (liek.inj.+liek.inj.)
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
B02BD04 Coagulation factor IX
Shelf life: 24
Container: 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: 20.04.2010
Pediatric posology: Yes
SPC: SPC_Octanine F 500 IU_1000 IU_05.2021.pdf  
PIL: PIL_Octanine F 500 IU_1000 IU_05.2021.pdf  
Safety feature Yes
Data update: 09.11.2018
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