This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Xenical : EPAR - Summary for the public (PDF/81.48 KB)
First published: 13/11/2008
Last updated: 13/11/2008
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
CHEPLAPHARM Arzneimittel GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
02/05/2017 Xenical - EMEA/H/C/000154 - T/0076
- 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.
excluding diet products
Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI > 28 kg/m2) with associated risk factors.
Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.
European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection19/11/2013
European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations23/10/2012
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 201217/02/2012