CERDELGA

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

Active ingredients

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

1 Eliglustat
UNII N0493335P3 - ELIGLUSTAT TARTRATE

Eliglustat is a potent and specific inhibitor of glucosylceramide synthase, and acts as a substrate reduction therapy (SRT) for GD1.

Read about Eliglustat

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
CERDELGA Hard capsule 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
A16AX10 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 A16AX10

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): 502819120079017, 576720050068817
Country: CA Health Products and Food Branch Identifier(s): 02463261
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 2465-MEE-1216
Country: EE Ravimiamet Identifier(s): 1676022, 1676033, 1713675
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 114974001
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 107940
Country: FR Base de données publique des médicaments Identifier(s): 61414553
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 346665
Country: IE Health Products Regulatory Authority Identifier(s): 88969
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 8004
Country: JP 医薬品医療機器総合機構 Identifier(s): 3999037M1023
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1075655, 1075656, 1080499
Country: NL Z-Index G-Standaard, PRK Identifier(s): 135852
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100335335
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W63456001, W63456002
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699809156784
Country: US FDA, National Drug Code Identifier(s): 58468-0220

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.