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PRODUCT DETAIL

Octaplex

Code 36360
MA number 16/0401/06-S
Product Form: plv fol 1x500 IU+solv.(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: 24.10.2006
Pediatric warnings: Yes
PIL: PIL_Octaplex_500_1000 IU_09.2020.doc  
SPC: SPC_Octaplex_500_1000 IU_09.2020.doc  
Safety feature Yes
Data update: 30.05.2018
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