ZAVESCA

This brand name is authorized in Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Turkey, United Kingdom, United States

Active ingredients

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

1 Miglustat UNII ADN3S497AZ - MIGLUSTAT

Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids, and a pharmacokinetic enzyme stabiliser of cipaglucosidase alfa. Miglustat is indicated for the treatment of adult patients with mild to moderate type 1 Gaucher disease and for the treatment of progressive neurological manifestations in patients with Niemann-Pick type C disease. Also, miglustat must be used in combination with cipaglucosidase alfa for long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency). Read about Miglustat

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ZAVESCA Capsule, hard	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
A16AX06	Miglustat	A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products
Discover more medicines within A16AX06

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 514520040036817
Country: CA	Health Products and Food Branch	Identifier(s): 02250519
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 76-MEE-0214
Country: EE	Ravimiamet	Identifier(s): 1196243
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 02238001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 016277
Country: FR	Base de données publique des médicaments	Identifier(s): 65793983
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 95042
Country: IE	Health Products Regulatory Authority	Identifier(s): 88229
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7846
Country: IT	Agenzia del Farmaco	Identifier(s): 035798014
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1031327
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 69620
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13900
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100140560
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699593151262
Country: US	FDA, National Drug Code	Identifier(s): 66215-201