| Code | 2250E | ||||||||||
| MA number | 16/0266/22-S | ||||||||||
| Product Form: | tbl flm 30x15 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| 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: | 27.10.2022 |
| Validity: | 27.10.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| Dokument: |
VHS_SK_H_0260_001-005_DC_Vixargio_PAR.doc
|
| Dokument: |
VHS_SK_H_0260_001-005_DC_Vixargio_summary PAR.doc
|
| PIL: |
PIL_Vixargio 15 mg_20 mg filmom obalené tablety_11.2023.pdf
|
| SPC: |
SPC_Vixargio 15 mg filmom obalené tablety_12.2023.pdf
|
| Dokument: |
SK_Rivaroxaban_Vixargio_Karta pacienta_NOV_2023_ver 1.3.pdf
|
| Dokument: |
Príručka pre lekára_rivaroxabán_V4.pdf
|
| Safety feature | Yes |
| Data update: | 05.12.2023 |
