XENICAL

This brand name is authorized in Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug XENICAL contains one active pharmaceutical ingredient (API):

1 Orlistat UNII 95M8R751W8 - ORLISTAT

Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases. The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides. Read about Orlistat

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XENICAL Capsule	FDA, National Drug Code (US)	MPI, US: SPL/PLR
XENICAL Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A08AB01	Orlistat	A Alimentary tract and metabolism → A08 Antiobesity preparations, excl. diet products → A08A Antiobesity preparations, excl. diet products → A08AB Peripherally acting antiobesity products
Discover more medicines within A08AB01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 4570M
Country: CA	Health Products and Food Branch	Identifier(s): 02240325
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 4903-MEE-1219
Country: EE	Ravimiamet	Identifier(s): 1042388, 1063684, 1063695, 1888342
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 98071002IP, 98071003, 98071003IP, 98071003IP1, 98071003IP3, 98071003IP4, 98071003IP5, 98071003IP6, 98071003IP7
Country: FR	Base de données publique des médicaments	Identifier(s): 65715632
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 19237, 381763
Country: HK	Department of Health Drug Office	Identifier(s): 44752
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4166
Country: IT	Agenzia del Farmaco	Identifier(s): 034195014, 034195026, 034195038, 034195040, 034195053, 034195065, 039859018, 040017016, 041435013, 044419012, 045405014, 046183012, 046329013, 050847019
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1014357, 1031407, 1031408, 1031409, 1031410, 1031411
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 51535
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 7932
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100237124
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W63610001, W63610002
Country: SG	Health Sciences Authority	Identifier(s): 13046P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8682340179046
Country: US	FDA, National Drug Code	Identifier(s): 61269-460
Country: ZA	Health Products Regulatory Authority	Identifier(s): 32/11.3.1/0475