| Code | 3631E | ||||||||||
| MA number | 16/0127/23-S | ||||||||||
| Product Form: | tbl flm 98x10 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 30 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 21.06.2023 |
| Validity: | 21.06.2028 |
| SPC: |
SPC_Xiltess 10 mg_01.2024.pdf
|
| PIL: |
PIL_Xiltess 10 mg_01.2024.pdf
|
| Dokument: |
Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf
|
| Safety feature | Yes |
| Data update: | 28.06.2023 |
