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PRODUCT DETAIL

ADYNOVI 3 000 IU/5 ml prášok a rozpúšťadlo na injekčný roztok

Code 9627D
MA number EU/1/17/1247/016
Product Form: plv iol 1x3 000 IU + 1xsolv.5 ml (liek.inj.skl.+spojené s pomôckou na rekonšt.)
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: 24
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: 08.01.2018
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 24.01.2023
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