🇪🇺 Xenical in European Union

EMA authorised Xenical on 29 July 1998

Marketing authorisation

EMA — authorised 29 July 1998

  • Application: EMEA/H/C/000154
  • Marketing authorisation holder: CHEPLAPHARM Arzneimittel GmbH
  • Local brand name: Xenical
  • 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.
  • Status: approved

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Xenical in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in European Union

Frequently asked questions

Is Xenical approved in European Union?

Yes. EMA authorised it on 29 July 1998.

Who is the marketing authorisation holder for Xenical in European Union?

CHEPLAPHARM Arzneimittel GmbH holds the EU marketing authorisation.