CHOLURSO Film-coated tablet Ref.[27920] Active ingredients: Ursodeoxycholic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Laboratoires Mayoly Spindler, 6 avenue de lEurope, BP 51, CHATOU Cedex, France

Product name and form

Cholurso 250 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round (11 mm diameter), biconvex film-coated tablet.

Qualitative and quantitative composition

Each tablet contains 250 mg of ursodeoxycholic acid.

Excipient with known effect: soya lecithin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ursodeoxycholic acid

The ursodeoxycholic acid converts lithogenic bile in non-lithogenic bile and gradually dissolves the cholesterol gallstones.

List of Excipients

Core:

Maize starch
Sodium laurilsulfate
Povidone K30 (E1201)
Anhydrous colloidal silica
Magnesium stearate

Film-coat:

Lecithin (Soya) (E322)
Macrogol 3350 (E1521)
Polyvinyl alcohol (E1203)
Talc (E553b)
Titanium dioxide (E171)

Pack sizes and marketing

20, 30, 50, 60 or 100 tablets in blister packs (PVC / PVDC / Aluminium).

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoires Mayoly Spindler, 6 avenue de l’Europe, BP 51, CHATOU Cedex, France

Marketing authorization dates and numbers

PA1913/002/001

Date of first authorisation: 13 October 2017
Date of latest renewal: 19 December 2019

Drugs

Drug Countries
CHOLURSO France, Ireland, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.