| Code | 3548E | ||||||||||
| MA number | 16/0107/23-S | ||||||||||
| Product Form: | tbl flm 28x10 mg (blis.PVC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Swyssi AG, Germany | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 16.05.2023 |
| Validity: | 16.05.2028 |
| PIL: |
PIL_Closderive 10 mg filmom obalené tablety_04_2023.pdf
|
| SPC: |
SPC_Closderive 10 mg filmom obalené tablety_04_2023.pdf
|
| Dokument: |
Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf
|
| Safety feature | Yes |
| Data update: | 30.05.2023 |
