| Code | 6498D | ||||||||||
| MA number | EU/1/18/1324/006 | ||||||||||
| Product Form: | plv iol 30x250 IU + 2,5 solv. (liek.inj.skl.+striek.inj.napl.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Bayer AG, Germany | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 24 | ||||||||||
| 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: | 22.11.2018 | 
| SmPC + PL: |  | 
| Safety feature | Yes | 
| Data update: | 29.06.2023 |