Code | 4106E | ||||||||||
MA number | 16/0170/23-S | ||||||||||
Product Form: | tbl flm 45x1x15 mg (blis.PVC/PVDC/Al-jednotliv.dáv.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
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: | 10.08.2023 |
Validity: | 10.08.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Bevimlar 15 mg_tbl flm_03_2024.pdf |
PIL: | PIL_Bevimlar 15 mg_20 mg_tbl flm_03_2024.pdf |
Dokument: | Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf |
Safety feature | Yes |
Data update: | 14.08.2023 |