PROLIA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Denosumab
UNII 4EQZ6YO2HI - DENOSUMAB

Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.

Read about Denosumab

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
PROLIA Solution for injection European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

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

ATC code Group title Classification
M05BX04 Denosumab 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 M05BX04

Authorization and marketing

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): 5457F
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 544116090003517
Country: CA Health Products and Food Branch Identifier(s): 02343541
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 208-MBE-0721
Country: EE Ravimiamet Identifier(s): 1481857, 1481868
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 10618003
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 085792
Country: FR Base de données publique des médicaments Identifier(s): 64256891
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 173019
Country: HK Department of Health Drug Office Identifier(s): 60588, 60589
Country: IE Health Products Regulatory Authority Identifier(s): 65460, 76815
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 6726
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1055468, 1055469, 1055470
Country: NL Z-Index G-Standaard Identifier(s): 15654486
Country: NL Z-Index G-Standaard, PRK Identifier(s): 96261
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 14646
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100221991
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W55639001, W55639003, W55639004
Country: SG Health Sciences Authority Identifier(s): 14024P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699862950251
Country: US FDA, National Drug Code Identifier(s): 55513-710
Country: ZA Health Products Regulatory Authority Identifier(s): 54/30.1/0205

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