This brand name is authorized in Austria, Australia, Brazil, Canada, Estonia, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States
The drug EVENITY contains one active pharmaceutical ingredient (API):
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1
Romosozumab
UNII 3VHF2ZD92J - ROMOSOZUMAB
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Romosozumab is a humanized monoclonal antibody (IgG2) that binds and inhibits sclerostin, thereby increasing bone formation due to the activation of bone lining cells, increasing bone matrix production by osteoblasts, and recruitment of osteoprogenitor cells. Additionally, romosozumab results in changes to expression of osteoclast mediators, thereby decreasing bone resorption. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| EVENITY Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC | |
| EVENITY 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 |
|---|---|---|
| M05BX06 | 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: AU | Pharmaceutical Benefits Scheme | Identifier(s): 12301K |
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 544121030005402 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02489597 |
| Country: EE | Ravimiamet | Identifier(s): 1808524, 1808535, 1808546, 1808557 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 381593 |
| Country: HK | Department of Health Drug Office | Identifier(s): 66741 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8507 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 3999449G1025 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1089061, 1089063, 1089064, 1089065 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 207063 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100429823, 100429830 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W68906001 |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699862950244 |
| Country: US | FDA, National Drug Code | Identifier(s): 55513-880 |
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