This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Ecuador, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Spain, Turkey, UK.
The drug CERDELGA contains one active pharmaceutical ingredient (API):
1
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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. SRT aims to reduce the rate of synthesis of the major substrate glucosylceramide (GL-1) to match its impaired rate of catabolism in patients with GD1, thereby preventing glucosylceramide accumulation and alleviating clinical manifestations. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| CERDELGA Hard capsule | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | 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) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 502819120079017, 576720050068817 |
| CA | Health Products and Food Branch | 02463261 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 2465-MEE-1216 |
| EE | Ravimiamet | 1676022, 1676033, 1713675 |
| ES | Centro de información online de medicamentos de la AEMPS | 114974001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 107940 |
| FR | Base de données publique des médicaments | 61414553 |
| GB | Medicines & Healthcare Products Regulatory Agency | 346665 |
| IE | Health Products Regulatory Authority | 88969 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 8004 |
| JP | 医薬品医療機器総合機構 | 3999037M1023 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1075655, 1075656, 1080499 |
| NL | Z-Index G-Standaard, PRK | 135852 |
| PL | Rejestru Produktów Leczniczych | 100335335 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W63456001, W63456002 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699809156784 |
| US | FDA, National Drug Code | 58468-0220 |
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