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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List item
Alli : EPAR - Summary for the public (PDF/50.5 KB)
First published: 30/04/2009
Last updated: 28/11/2012 -
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List item
Alli : EPAR - Risk-management-plan summary (PDF/46.77 KB)
First published: 31/03/2021
Authorisation details
Product details | |
---|---|
Name |
Alli (previously Orlistat GSK)
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Agency product number |
EMEA/H/C/000854
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Active substance |
orlistat
|
International non-proprietary name (INN) or common name |
orlistat
|
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 |
18
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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
22/12/2021 Alli (previously Orlistat GSK) - EMEA/H/C/000854 - N/0065
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.