This brand name is authorized in Austria, Spain, France, Croatia, Ireland, Italy, Lithuania, United Kingdom
The drug OPFOLDA contains one active pharmaceutical ingredient (API):
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1
Miglustat
UNII ADN3S497AZ - MIGLUSTAT
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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). |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| OPFOLDA Hard capsule | European Medicines Agency (EU) | MPI, EU: SmPC |
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 |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1231737001 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 61479921 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 050750013, 050750025 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1097305, 1097306 |
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