Alli (previously Orlistat GSK)

RSS

orlistat

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Alli. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Alli.

This EPAR was last updated on 04/12/2018

Authorisation details

Product details
Name
Alli (previously Orlistat GSK)
Agency product number
EMEA/H/C/000854
Active substance
orlistat
International non-proprietary name (INN) or common name
orlistat
Therapeutic area (MeSH)
Obesity
Anatomical therapeutic chemical (ATC) code
A08AB01
Publication details
Marketing-authorisation holder
GlaxoSmithKline (Ireland) Limited
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
22/07/2007
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

26/11/2018 Alli (previously Orlistat GSK) - EMEA/H/C/000854 - T/0059

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Antiobesity preparations
  • excl. diet products

Therapeutic indication

Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥ 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.

Assessment history

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