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PRODUCT DETAIL

Kovaltry 1000 IU prášok a rozpúšťadlo na injekčný roztok

Code 5733C
MA number EU/1/15/1076/016
Product Form: plv iol 1x1000 IU+2,5 ml solv. (liek.inj.skl.+adapt.+striek.inj.skl.napl.-5 ml)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Bayer AG, Germany
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: 30
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 18.02.2016
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 12.10.2020
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