Product class: Authorized package
Medicinal product class: For human use
Package code: 1712180
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: 252TK
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 21 January 2020)
Package information leaflet (PIL): EST  (last updated 21 January 2020)
Labelling:  (last updated 19 December 2018)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 760611 
Marketing authorization issued on: 26 September 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 16 November 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription