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PRODUCT DETAIL

Octaplex 1 000 IU prášok a rozpúšťadlo na infúzny roztok

Code 0509C
MA number 75/0205/16-S
Product Form: plv fol 1x1000 IU+1x40 ml solv. (liek.inj.skl.+liek.inj.skl.+transf.súprava)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
MAH, country: Octapharma (IP) SPRL, Belgium
Therapeutic Class: 75 - SUBSTITUTIO SANGUINIS (A KRVNÉ DERIVÁTY)
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: 27.07.2016
Pediatric warnings: Yes
SPC: SPC_Octaplex_500 IU_1000 IU_06.2024.pdf  
PIL: PIL_Octaplex_500 IU_1000 IU_06.2024.pdf  
Safety feature Yes
Data update: 11.02.2021
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