Alli (previously Orlistat GSK)
orlistat
Table of contents
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.
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Alli : EPAR - Summary for the public (PDF/50.5 KB)
First published: 30/04/2009
Last updated: 28/11/2012 -
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Alli : EPAR - Risk-management-plan summary (PDF/46.77 KB) (new)
First published: 31/03/2021
Authorisation details
Product details | |
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Name |
Alli (previously Orlistat GSK)
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Agency product number |
EMEA/H/C/000854
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Active substance |
orlistat
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International non-proprietary name (INN) or common name |
orlistat
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Therapeutic area (MeSH) |
Obesity
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Anatomical therapeutic chemical (ATC) code |
A08AB01
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Publication details | |
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Marketing-authorisation holder |
GlaxoSmithKline (Ireland) Limited
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Revision |
17
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Date of issue of marketing authorisation valid throughout the European Union |
22/07/2007
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Contact address |
12 Riverwalk |
Product information
22/07/2020 Alli (previously Orlistat GSK) - EMEA/H/C/000854 - IB/0062/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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.