Code | 7038E | ||||||||||
MA number | EU/1/24/1837/001 | ||||||||||
Product Form: | plv iol 1x500 IU + 5 ml solv. (liek.inj.skl.+zar.BAXJECT II Hi-Flow) | ||||||||||
MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Takeda Manufacturing Austria AG, Austria | ||||||||||
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: | 01.08.2024 |
Validity: | 01.08.2029 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 09.08.2024 |