| Code | 6437D | ||||||||||
| MA number | 16/0016/21-S | ||||||||||
| Product Form: | tbl flm 100x2,5 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 11.03.2021 |
| Validity: | 11.03.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Rivaroxaban G.L. Pharma 2,5 mg_tbl flm_03.2024.pdf
|
| PIL: |
PIL_Rivaroxaban G.L. Pharma 2,5 mg_tbl flm_03.2024.pdf
|
| Dokument: |
Príručka pre lekára_rivaroxabán_V3.pdf
|
| Safety feature | Yes |
| Data update: | 21.11.2023 |
