XENICAL Hard capsule Ref.[7912] Active ingredients: Orlistat

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Product name and form

Xenical 120 mg hard capsules.

Pharmaceutical Form

Hard capsule.

The capsule has a turquoise cap and turquoise body bearing the imprint of “XENICAL 120”.

Qualitative and quantitative composition

Each hard capsule contains 120 mg orlistat.

For a full list of excipients, see 6.1.

Active Ingredient Description
Orlistat

Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases. The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides.

List of Excipients

Capsule filling:

Microcrystalline cellulose (E460)
Sodium starch glycolate (type A)
Povidone (E1201)
Sodium laurilsulfate
Talc

Capsule shell:

Gelatine
Indigo carmine (E132)
Titanium dioxide (E171)
Edible printing ink (black iron oxide, ammonia solution concentrated, potassium hydroxide, shellac, propylene glycol)

Pack sizes and marketing

PVC/PVDC blisters containing 21, 42 and 84 hard capsules. Glass bottles with desiccant containing 21, 42 and 84 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Marketing authorization dates and numbers

EU/1/98/071/001-006

Date of first authorisation: 29 July 1998
Date of latest renewal: 17 June 2008

Drugs

Drug Countries
XENICAL Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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