EVENITY

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Estonia, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, UK.

Active ingredients

The drug EVENITY contains one active pharmaceutical ingredient (API):

1
UNII 3VHF2ZD92J - ROMOSOZUMAB
 

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.

 
Read more about Romosozumab

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 EVENITY Solution for injection MPI, EU: SmPC European Medicines Agency (EU)
 EVENITY Solution for injection MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group 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
Discover more medicines within M05BX06

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 12301K
BR Câmara de Regulação do Mercado de Medicamentos 544121030005402
CA Health Products and Food Branch 02489597
EE Ravimiamet 1808524, 1808535, 1808546, 1808557
GB Medicines & Healthcare Products Regulatory Agency 381593
HK Department of Health Drug Office 66741
IL מִשְׂרַד הַבְּרִיאוּת 8507
JP 医薬品医療機器総合機構 3999449G1025
LT Valstybinė vaistų kontrolės tarnyba 1089061, 1089063, 1089064, 1089065
NL Z-Index G-Standaard, PRK 207063
PL Rejestru Produktów Leczniczych 100429823, 100429830
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W68906001
TR İlaç ve Tıbbi Cihaz Kurumu 8699862950244
US FDA, National Drug Code 55513-880

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.