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PRODUCT DETAIL

Ursofalk 250 mg/5 ml suspenzia

Code 53549
MA number 43/0543/08-S
Product Form: sus por 2x250 ml (fľ.skl.hnedá)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 43 - CHOLERETICA, CHOLEKINETICA
ATC:
A ALIMENTARY TRACT AND METABOLISM
A05 BILE AND LIVER THERAPY
A05A BILE THERAPY
A05AA Bile acids and derivatives
A05AA02 Ursodeoxycholic acid
Shelf life: 48
Container: brown glass bottle
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 15.10.2008
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric contraindication: Yes
PIL: PIL_Ursofalk 250 mg_5ml suspenzia_november2020.docx  
SPC: SPC_Ursofalk 250 mg_5ml suspenzia_november2020.docx  
Safety feature Yes
Data update: 15.04.2019
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