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PRODUCT DETAIL

ELOCTA 4000 IU prášok a rozpúšťadlo na injekčný roztok

Code 0353D
MA number EU/1/15/1046/008
Product Form: plv iol 1x4000 IU+ 3 ml solv. (liek.inj.skl.+striek.inj.napl.skl.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
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: 48
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 07.12.2018
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 11.09.2020
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