Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ORLISTAT SANDOZ 120 MG
Active substances:
Orlistat
Estonian, English, Latin
ATC code: A08AB01
Dosage form: capsule, hard
Strength: 120mg
Legal status for supply*: Subject to medicinal prescription
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)
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
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1424528  ORLISTAT SANDOZ 120 MG  capsule, hard  120mg 21TK  Prescription           
1424539  ORLISTAT SANDOZ 120 MG  capsule, hard  120mg 42TK  Prescription           
1424540  ORLISTAT SANDOZ 120 MG  capsule, hard  120mg 84TK  Prescription           
1712180  ORLISTAT SANDOZ 120 MG  capsule, hard  120mg 252TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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