Code | 90099 | ||||||||||
MA number | 16/0118/81-CS | ||||||||||
Product Form: | plv iol 1x600 IU+1x10 ml solv. (liek.skl.+liek.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | National | ||||||||||
MAH, country: | Baxalta Innovations GmbH, Austria | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass container | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 30.03.1981 |
Dokument: | DHPC Factor VII 9 11 2015 Baxter.pdf |
SPC: | SPC_FACTOR VII NF Baxalta_04.2021.pdf |
PIL: | PIL_FACTOR VII NF Baxalta_05.2022.pdf |
Safety feature | Yes |
Data update: | 20.02.2018 |