This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug CEREZYME contains one active pharmaceutical ingredient (API):
1
|
UNII
Q6U6J48BWY - IMIGLUCERASE
|
|
Imiglucerase is a recombinant macrophage targeted acid β-glucosidase that replaces the deficient enzyme activity, hydrolysing glucosylceramide, thus correcting initial pathophysiology and preventing secondary pathology. Imiglucerase has been shown to improve both mental and physical aspects in the quality of life of Gaucher disease. |
|
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| CEREZYME Powder for concentrate for solution for infusion | 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 | |
|---|---|---|
| A16AB02 | Imiglucerase | A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AB Enzymes |
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 | 502818100077817, 576720040062117 |
| CA | Health Products and Food Branch | 02241751 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | H7781013 |
| EE | Ravimiamet | 1129867, 1129878, 1129889, 1129890, 1129902 |
| ES | Centro de información online de medicamentos de la AEMPS | 97053003 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 465609 |
| FR | Base de données publique des médicaments | 62616337 |
| GB | Medicines & Healthcare Products Regulatory Agency | 48780 |
| HK | Department of Health Drug Office | 60392 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6459 |
| JP | 医薬品医療機器総合機構 | 3959406D2021 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1007025, 1007026, 1028071, 1028072, 1028073 |
| NL | Z-Index G-Standaard | 14624273 |
| NL | Z-Index G-Standaard, PRK | 58319 |
| NZ | Medicines and Medical Devices Safety Authority | 14478 |
| PL | Rejestru Produktów Leczniczych | 100097730, 100212710 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W08253001, W08253002, W08253003 |
| SG | Health Sciences Authority | 13842P |
| TN | Direction de la Pharmacie et du Médicament | 3843031H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699809260047 |
| US | FDA, National Drug Code | 58468-1983, 58468-4663 |
| ZA | Health Products Regulatory Authority | 36/31/0179 |
© 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.