Code | 9267C | ||||||||||
MA number | EU/1/18/1298/001 | ||||||||||
Product Form: | plv iol 1x650 IU + 1x5 ml solv. (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Baxalta Innovations GmbH, Austria | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
|
||||||||||
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: | 31.08.2018 |
SmPC + PL: |
|
Safety feature | Yes |
Data update: | 03.07.2023 |