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PRODUCT DETAIL

Esperoct 4 000 IU prášok a rozpúšťadlo na injekčný roztok

Code 4704E
MA number EU/1/19/1374/006
Product Form: plv iol 1x4000 IU + 1x4 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: 36
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: 20.06.2019
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 14.03.2024
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