PROURSAN Capsule, hard Ref.[50968] Active ingredients: Ursodeoxycholic acid

Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: PRO.MED.CS Praha a.s., Telcska 377/1, Praha 4, Michle, 14000, Czech Republic

Product name and form

Proursan 250mg Capsules, Hard.

Pharmaceutical Form
Capsule, hard. White, hard gelatine capsules containing white or almost white powder.

Qualitative and quantitative composition

Each hard capsule contains 250 mg ursodeoxycholic acid (UDCA) as the active ingredient.

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
Maize starch Maize starch, pregelatinised Silica, colloidal anhydrous Magnesium stearate Gelatin Titanium dioxide (E171)

Pack sizes and marketing

PVC/PVdC and Al blister, carton.

Pack size: 10, 30, 50, 60, 90 or 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

PRO.MED.CS Praha a.s., Telcska 377/1, Praha 4, Michle, 14000, Czech Republic

Marketing authorization dates and numbers

PA2179/002/001

Date of first authorisation: 12^th May 2017
Date of last renewal: 20^th March 2022

Drugs

Drug	Countries
PROURSAN	Ireland, Poland, Turkey

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