URSODEOXYCHOLIC ACID Tablet Ref.[7799] Active ingredients: Ursodeoxycholic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom

Product name and form

Ursodeoxycholic acid 150 mg tablets.

Pharmaceutical Form

Tablet.

Ursodeoxycholic acid 150 mg Tablets: White to off-white, round shaped uncoated tablets approximately 9.50 mm in size with breakline and “G” “442” engraved on one side and plain on the other side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each Ursodeoxycholic acid 150 mg Tablet contains 150 mg of ursodeoxycholic acid (UDCA).

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

Cellulose microcrystalline (Microcel 101) (E460)
Polyvinyl pyrrolidone (Plasdone K-90) (E1201)
Magnesium Stearate (E572)
Sodium Starch Glycolate Type A (Primojel)

Pack sizes and marketing

Clear PVC/PVDC – plain aluminium foil.

Pack size: 20, 30, 50, 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom

Marketing authorization dates and numbers

PL 25258/0266

Date of first authorization: 21/05/2018

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