| Code | 2786E | ||||||||||
| MA number | 16/0021/23-S | ||||||||||
| Product Form: | sol iru 30x4 000 IU (40 mg)/0,4 ml (striek.inj.napl.skl. bez bezp. systému) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Extracorporeal, intravenous and subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(4) similar biological application |
| MA issued: | 15.02.2023 |
| Validity: | 15.02.2028 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Ledraxen_injekčný roztok v naplnenej injekčnej striekačke_01_2023.pdf
|
| SPC: |
SPC_Ledraxen_injekčný roztok v naplnenej injekčnej striekačke_01_2023.pdf
|
| Safety feature | Yes |
| Data update: | 21.02.2023 |
