PROLIA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, 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: IT	Agenzia del Farmaco	Identifier(s): 040108019, 040108021, 040108033
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