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URSOSAN
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1771286
Name of medicinal product:
URSOSAN
Active substances:
Ursodeoxycholic acid
Estonian
,
English
,
Latin
ATC code:
A05AA02
Dosage form:
capsule, hard
Route of administration:
oral use
Strengh:
250mg
Amount in package:
40TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated March 24, 2023)
Package information leaflet (PIL):
EST
(last updated March 24, 2023)
Labelling:
(last updated April 22, 2020)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Pro.Med.Cs Praha a.s.
Marketing authorization number:
369601
Marketing authorization issued on:
December 7, 2001
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
National
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: February 8, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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