| Code | 8942E | ||||||||||
| MA number | 16/0026/25-S | ||||||||||
| Product Form: | tbl flm 10x1x30 mg (blis.Al-PVC/PE/PVDC - jednotk.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 22.02.2025 | 
| Validity: | 22.02.2030 | 
| PIL: |  | 
| SPC: |  | 
| Safety feature | Yes | 
| Data update: | 24.02.2025 |