Xenical (orlistat)
- Region
- 🇪🇺 EU
- Active substance
- orlistat
- Company
- CHEPLAPHARM Arzneimittel GmbH
- Status
- Authorised
- Therapeutic area
- Obesity
- EU approval
- Wed 29 Jul 1998
- Application
- EMEA/H/C/000154
- ATC
- A08AB01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Alli (previously Orlistat GSK) Authorised · Haleon Ireland Dungarvan Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.