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PRODUCT DETAIL

Xiltess 20 mg

Code 3638E
MA number 16/0129/23-S
Product Form: tbl flm 98x20 mg (blis.OPA/Al/PVC/Al)
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 OPA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 21.06.2023
Validity: 21.06.2028
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Xiltess 20mg_05_2023.pdf  
PIL: PIL_Xiltess 20 mg_05_2023.pdf  
Safety feature Yes
Data update: 28.06.2023
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