PRODUCT DETAIL

URSOSAN FORTE 500 mg filmom obalené tablety

Code

4374C

MA number

43/0122/17-S

Product Form:

tbl flm 90x500 mg (blis.PVC/PVDC/Al)

MA Status:

D - Marketing Authorisation valid for an unlimited period

Type of procedure:

Decentralised

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:

Container:

blister PVC/PVDC/Al

Route of admin.:

Oral use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	15.06.2017
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric contraindication:	Yes
SPC:	SPC_URSOSAN FORTE 500 mg filmom obalené tablety_07_2019.docx
PIL:	PIL_URSOSAN FORTE 500 mg filmom obalené tablety_07_2019.docx
Safety feature	Yes
Data update:	23.12.2021