This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Ecuador, Estonia, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, UK.
The drug VIMIZIM contains one active pharmaceutical ingredient (API):
1
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UNII
ODJ69JZG85 - ELOSULFASE ALFA
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Elosulfase alfa is a recombinant form of human N-acetylgalactosamine-6-sulfatase (rhGALNS) used for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA). Elosulfase alfa is intended to provide the exogenous enzyme N-acetylgalactosamine-6-sulfatase that will be taken up into the lysosomes and increase the catabolism of the GAGs KS and C6S. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| VIMIZIM Concentrate for solution for infusion | MPI, EU: SmPC | European Medicines Agency (EU) | |
| VIMIZIM Concentrate solution for injection | MPI, US: SPL/PLR | FDA, National Drug Code (US) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| A16AB12 | 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 | 542417020000102 |
| CA | Health Products and Food Branch | 02427184 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 69-MBE-0816 |
| EE | Ravimiamet | 1647277 |
| FR | Base de données publique des médicaments | 61673965 |
| GB | Medicines & Healthcare Products Regulatory Agency | 341686 |
| HK | Department of Health Drug Office | 63775 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7643 |
| IT | Agenzia del Farmaco | 043377011 |
| JP | 医薬品医療機器総合機構 | 3959417A1027 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1073356 |
| NL | Z-Index G-Standaard | 16091973 |
| NL | Z-Index G-Standaard, PRK | 124265 |
| NZ | Medicines and Medical Devices Safety Authority | 17526 |
| PL | Rejestru Produktów Leczniczych | 100315723 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W66181001 |
| US | FDA, National Drug Code | 68135-100 |
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