ZAVESCA

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

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 more about Miglustat

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ZAVESCA Capsule, hard	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

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