| Code | 5417E | ||||||||||
| MA number | 16/0019/24-S | ||||||||||
| Product Form: | tbl flm 100x1x15 mg (blis.PVC/PE/PVdC/Al-jednotk.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 15.02.2024 |
| Validity: | 15.02.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_XABOPLAX 15 mg filmom obalené tablety_07.2024.pdf
|
| PIL: |
PIL_XABOPLAX 15 mg_20 mg filmom obalené tablety_07.2024.pdf
|
| Dokument: |
Príručka pre lekára_rivaroxabán_V4.pdf
|
| Safety feature | Yes |
| Data update: | 21.02.2024 |
