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URSOSAN
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1737176
Name of medicinal product:
URSOSAN
Active substances:
Ursodeoxycholic acid
Estonian
,
English
,
Latin
ATC code:
A05AA02
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
500mg
Amount in package:
30TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
For dissolution of cholesterol gallstones of the gall bladder. The gallstones must not produce any shadows on the radiograph and should not be of a greater diameter than 15 mm, and the gall bladder, despite the gallstone(s), must be functioning. For symptomatic treatment of primary biliary cholangitis (PBC), as long as there is no decompensated cirrhosis of the liver. Paediatric population For treatment of hepatobiliary disease associated with cystic fibrosis in children aged 6 to 18 years.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated December 5, 2022)
Package information leaflet (PIL):
EST
(last updated July 3, 2018)
Labelling:
(last updated July 3, 2018)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Pro.Med.Cs Praha a.s.
Marketing authorization number:
968018
Marketing authorization issued on:
July 3, 2018
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: September 12, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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