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PRODUCT DETAIL

OCTANATE 1000 I.U.

Code 15009
MA number 16/0018/00-S
Product Form: plv iol 1x1000 I.U.+ 10 ml solv.
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
B02BD02 Coagulation factor VIII
Shelf life: 24
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: 07.02.2000
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_OCTANATE 250 IU_500 IU_1000 IU_01.2024.pdf  
PIL: PIL_OCTANATE 250 IU_500 IU_1000 IU_01.2024.pdf  
Safety feature Yes
Data update: 30.05.2018
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