Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1042388
|
Name of medicinal product:
|
XENICAL
|
Active substances:
|
|
ATC code:
|
A08AB01
|
Dosage form:
|
capsule, hard
|
Route of administration:
|
oral use
|
Strengh:
|
120mg
|
Amount in package:
|
21TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
blister
|
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.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
November 27, 2018
|
Marketing authorization holder:
|
Cheplapharm Arzneimittel GmbH
|
Marketing authorization number:
|
EU/1/98/071
|
Marketing authorization issued on:
|
June 14, 1999
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
May 12, 2017
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere