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, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug FABRAZYME contains one active pharmaceutical ingredient (API):
1
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UNII
RZD65TSM9U - AGALSIDASE BETA
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Agalsidase beta is a recombinant form of human α-galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture. The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α-galactosidase. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| FABRAZYME Powder for concentrate solution | 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 | |
|---|---|---|
| A16AB04 | Agalsidase beta | 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 | 576720020056117 |
| CA | Health Products and Food Branch | 02248965, 02248966 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 133-MBE-0319, 8-MBE-0514 |
| EE | Ravimiamet | 1127359, 1127663, 1209732, 1209743, 1209765, 1209776 |
| ES | Centro de información online de medicamentos de la AEMPS | 01188001, 01188004 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 006732, 016930 |
| FR | Base de données publique des médicaments | 64569676 |
| GB | Medicines & Healthcare Products Regulatory Agency | 95244, 95247 |
| HK | Department of Health Drug Office | 55821, 55822 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6737 |
| JP | 医薬品医療機器総合機構 | 3959409D1029, 3959409D2025 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1028369, 1028370, 1028371, 1028392, 1028393, 1028394 |
| NL | Z-Index G-Standaard | 14695898, 14889110 |
| NL | Z-Index G-Standaard, PRK | 60518, 70254 |
| PL | Rejestru Produktów Leczniczych | 100111357, 100212727 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W08961001, W08961002, W08961003, W52556001, W52556002, W52556003 |
| SG | Health Sciences Authority | 13609P, 13610P |
| TN | Direction de la Pharmacie et du Médicament | 3843041H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699809260054 |
| US | FDA, National Drug Code | 58468-0040, 58468-0041 |
| ZA | Health Products Regulatory Authority | 46/31/0583, 46/31/0584 |
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