| 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: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 09.08.2024 |
