This brand name is authorized in Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States
The drug CERDELGA contains one active pharmaceutical ingredient (API):
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1
Eliglustat
UNII N0493335P3 - ELIGLUSTAT TARTRATE
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|
Eliglustat is a potent and specific inhibitor of glucosylceramide synthase, and acts as a substrate reduction therapy (SRT) for GD1. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| CERDELGA 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 |
|---|---|---|
| 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 | |
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 |
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