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PRODUCT DETAIL

Rivaroxaban FMK 20 mg

Code 4780D
MA number 16/0135/20-S
Product Form: tbl flm 20x20 mg (blis.Al/PVC)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ATC:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AF Direct factor Xa inhibitors
B01AF01 Rivaroxaban
Shelf life: 36
Container: blister Al/PVC
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 10.06.2020
Validity: 10.06.2025
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Rivaroxaban FMK 20 mg_09.2023.pdf  
PIL: PIL_Rivaroxaban FMK 15 mg_20 mg_09.2023.pdf  
Safety feature Yes
Data update: 13.09.2023
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