XENICAL

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

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 more about Orlistat

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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