| Code | 4460D | ||||||||||
| MA number | 16/0105/20-S | ||||||||||
| Product Form: | tbl flm 100(10x10x1)x2,5 mg (blis.Al/PVC/PE/PVDC-jednotliv.dáv.v multibal.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 11.05.2020 |
| PIL: |
PIL_Assubex 2,5 mg_01.2024.pdf
|
| SPC: |
SPC_Assubex 2,5 mg_04.2024.pdf
|
| Dokument: |
Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf
|
| Dokument: |
Rivaroxabán_Príručka pre predpisujúceho lekára.pdf
|
| Safety feature | Yes |
| Data update: | 14.06.2024 |
