| Code | 3061F | ||||||||||
| MA number | 16/0091/26-S | ||||||||||
| Product Form: | plo ijf 1x2 g (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | CSL Behring GmbH, Germany | ||||||||||
| 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 medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 24.03.2026 |
| Validity: | 24.03.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Riastap 2 g_03_2026.pdf
|
| SPC: |
SPC_Riastap 2 g_03_2026.pdf
|
| Safety feature | Yes |
| Data update: | 25.03.2026 |
