This brand name is authorized in United States. It is also authorized in Austria, Brazil, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Poland, Singapore, South Africa, Spain, Turkey, UK.
The drug XOFIGO contains one active pharmaceutical ingredient (API):
1
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UNII
RJ00KV3VTG - RADIUM RA-223 DICHLORIDE
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Radium-223 dichloride mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. Radium-223 dichloride monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| XOFIGO Solution for injection | 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 | |
|---|---|---|
| V10XX03 | V Various → V10 Therapeutic radiopharmaceuticals → V10X Other therapeutic radiopharmaceuticals → V10XX Various therapeutic radiopharmaceuticals | |
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 | 538916110027307 |
| EE | Ravimiamet | 1632293 |
| ES | Centro de información online de medicamentos de la AEMPS | 113873001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 559995 |
| FR | Base de données publique des médicaments | 66302387 |
| GB | Medicines & Healthcare Products Regulatory Agency | 375222 |
| HK | Department of Health Drug Office | 64332 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 7423 |
| IT | Agenzia del Farmaco | 043116019 |
| JP | 医薬品医療機器総合機構 | 4291432A1025 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1072067 |
| PL | Rejestru Produktów Leczniczych | 100313552 |
| SG | Health Sciences Authority | 14478P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699546770083 |
| US | FDA, National Drug Code | 50419-208 |
| ZA | Health Products Regulatory Authority | 48/32.15/0715 |
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