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PRODUCT DETAIL

Rivaroxaban STADA 15 mg tvrdé kapsuly

Code 3718E
MA number 16/0145/23-S
Product Form: cps dur 56x1x15 mg (blis.PVC/PCTFE/PVC/Al-perfor.-jednotliv.dáv.)
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: 30
Container: blister PVC/PCTFE/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 27.06.2023
Validity: 27.06.2028
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Rivaroxaban STADA 15 mg tvrdé kapsuly_06_2023.pdf  
SPC: SPC_Rivaroxaban STADA 15 mg tvrdé kapsuly_06_2023.pdf  
Safety feature Yes
Data update: 03.07.2023
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