Code | 9503B | ||||||||||
MA number | EU/1/16/1095/004 | ||||||||||
Product Form: | plv iol 1x2000 IU+5 ml solv. (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | CSL Behring GmbH, Germany | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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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: | 11.05.2016 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 11.02.2021 |