This brand name is authorized in Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States
The drug CRYSVITA contains one active pharmaceutical ingredient (API):
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1
Burosumab
UNII G9WJT6RD29 - BUROSUMAB
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Burosumab is a recombinant human monoclonal antibody (IgG1) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23). By inhibiting FGF23, burosumab increases tubular reabsorption of phosphate from the kidney and increases serum concentration of 1,25 dihydroxy-Vitamin D. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| CRYSVITA Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC | |
| CRYSVITA Solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| M05BX05 | M Musculo-skeletal system → M05 Drugs for treatment of bone diseases → M05B Drugs affecting bone structure and mineralization → M05BX Other drugs affecting bone structure and mineralization | |
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): 597321080000217, 597321080000317, 597321080000417 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02483629, 02483637, 02483645 |
| Country: EE | Ravimiamet | Identifier(s): 1765672, 1765683, 1765694 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1171262001, 1171262002, 1171262003 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 089121, 429792, 589244 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60215018, 66071126, 67649597 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 358208, 358212, 358216 |
| Country: HK | Department of Health Drug Office | Identifier(s): 66641, 66642, 66643 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8296, 8753, 8875 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 3999452A1024, 3999452A2020, 3999452A3027 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1085106, 1085107, 1085108 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 151092, 151106, 151114 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100402623, 100402630, 100402646 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W65286001, W65287001, W65288001 |
| Country: US | FDA, National Drug Code | Identifier(s): 69794-102, 69794-203, 69794-304 |
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