URSOFALK Capsule, hard Ref.[50874] Active ingredients: Ursodeoxycholic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Dr Falk Pharma UK Ltd, Unit K, Bourne End Business Park, Cores End Road, Bourne End, Buckinghamshire, SL8 5AS

Product name and form

Ursofalk 250mg hard capsules.

Pharmaceutical Form
Capsule, hard. White, opaque, hard gelatin capsules (size 0) containing a white compressed powder or granules.

Qualitative and quantitative composition

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

For a 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
Ursofalk 250mg hard capsules contain the following excipients: Maize starch, silica colloidal anhydrous, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulphate.

Pack sizes and marketing

Clear PVC blister strips with aluminium foil backing packed in cardboard cartons. Available in cartons containing 60 capsules packaged in six blister strips of 10 capsules or 100 capsules packaged in 4 blister strips of 25 capsules.

Marketing authorization holder

Dr Falk Pharma UK Ltd, Unit K, Bourne End Business Park, Cores End Road, Bourne End, Buckinghamshire, SL8 5AS

Marketing authorization dates and numbers

PL 10341/0006

Date of First Authorisation: 31 December 2004
Date of Last Renewal: 14 November 2009

Drugs

Drug	Countries
URSOFALK	Austria, Australia, Cyprus, Germany, Ecuador, Estonia, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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