Code | 0397E | ||||||||||
MA number | 16/0056/22-S | ||||||||||
Product Form: | tbl flm 10x10 mg (blis.Al/PVC/PVDC) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister Al/PVC/PVDC | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 02.05.2022 |
Validity: | 02.05.2027 |
MA renewed: | Renewal application submitted |
SPC: | SPC_Rivaroxaban Reddy 10 mg tbl flm_02.2024.pdf |
PIL: | PIL_Rivaroxaban Reddy 10 mg tbl flm_02.2024.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
Safety feature | Yes |
Data update: | 05.05.2022 |