OPFOLDA

This brand name is authorized in Austria, Croatia, France, Ireland, Italy, Lithuania, Spain, UK.

Active ingredients

The drug OPFOLDA 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
OPFOLDA Hard capsule	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)
ES	Centro de información online de medicamentos de la AEMPS	1231737001
FR	Base de données publique des médicaments	61479921
IT	Agenzia del Farmaco	050750013, 050750025
LT	Valstybinė vaistų kontrolės tarnyba	1097305, 1097306