Register of
Medicinal Products
Human medicines
Veterinary medicines
Medical nutritions
User
Listings
Data download
Veterinary medicines
Search for medicinal products
Search for packages
ATC tree
Print
ORLISTAT SANDOZ 120 MG
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1424540
Name of medicinal product:
ORLISTAT SANDOZ 120 MG
Active substances:
Orlistat
Estonian
,
English
,
Latin
ATC code:
A08AB01
Dosage form:
capsule, hard
Route of administration:
oral use
Strengh:
120mg
Amount in package:
84TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
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):
(last updated January 21, 2020)
Package information leaflet (PIL):
EST
(last updated January 21, 2020)
Labelling:
(last updated December 19, 2018)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Sandoz Pharmaceuticals d.d.
Marketing authorization number:
760611
Marketing authorization issued on:
September 26, 2011
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: November 16, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader from
here