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PRODUCT DETAIL

Closderive 15 mg filmom obalené tablety

Code 3553E
MA number 16/0108/23-S
Product Form: tbl flm 42x15 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:
B BLOOD AND BLOOD FORMING ORGANS
B01 ANTITHROMBOTIC AGENTS
B01A ANTITHROMBOTIC AGENTS
B01AF Direct factor Xa inhibitors
B01AF01 Rivaroxaban
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
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Closderive 15 mg filmom obalené tablety_04_2023.pdf  
SPC: SPC_Closderive 15 mg filmom obalené tablety_04_2023.pdf  
Dokument: Príručka pre predpisujúceho lekára_rivaroxabán_V1.pdf  
Safety feature Yes
Data update: 30.05.2023
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