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

Drugs

Drug Countries
PROURSAN Ireland, Poland, Turkey

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