Code | 8630B | ||||||||||
MA number | EU/1/15/1076/010 | ||||||||||
Product Form: | plv iol 1x3000 IU+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: |
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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 |