Xenical

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). 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).

This EPAR was last updated on 15/05/2017

Authorisation details

Product details
Name
Xenical
Agency product number
EMEA/H/C/000154
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
CHEPLAPHARM Arzneimittel GmbH
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
28/07/1998
Contact address
Ziegelhof 24
17489 Greifswald
Germany

Product information

02/05/2017 Xenical - EMEA/H/C/000154 - T/0076

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
  • excluding diet products

Therapeutic indication

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.

Assessment history

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