URSOGRIX Capsule, hard Ref.[49916] Active ingredients: Ursodeoxycholic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: AS Grindeks, Krustpils Iela 53, Riga, 1057, Latvia

Product name and form

Ursogrix 250 mg hard capsules.

Pharmaceutical Form

Capsule, hard.

White hard gelatin capsules size 0, approximately 21.7 mm x 7.64 mm. The content – white or almost white powder.

Qualitative and quantitative composition

Each hard capsule contains 250 mg ursodeoxycholic acid.

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
Silicon dioxide (E551)
Magnesium stearate (E470B)

Hard gelatin capsule:

Body and cap composition
Titanium dioxide (E171)
Gelatin (E441)

Pack sizes and marketing

The capsules are packed in PVC/aluminium blisters.

10 capsules per blister. 5, 6 or 10 blisters (50, 60 or 100 capsules) are packed per cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

AS Grindeks, Krustpils Iela 53, Riga, 1057, Latvia

Marketing authorization dates and numbers

PA22992/002/001

Date of first authorisation: 26th February 2021
Date of last renewal: 21st December 2021

Drugs

Drug Countries
URSOGRIX Austria, Estonia, Croatia, Ireland, Lithuania, Malta, Romania

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