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EMA Product

Xenical

Product approved by European Medicines Agency (EU)

Basic Information

Xenical

Regulatory Information

EMEA/H/C/000154

Authorised

July 29, 1998

25

May 10, 2023

Company Information

Germany

Ziegelhof 24 17489 Greifswald

Cheplapharm Arzneimittel Gmbh

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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).

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