PROLIA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

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 more about Denosumab

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	5457F
BR	Câmara de Regulação do Mercado de Medicamentos	544116090003517
CA	Health Products and Food Branch	02343541
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	208-MBE-0721
EE	Ravimiamet	1481857, 1481868
ES	Centro de información online de medicamentos de la AEMPS	10618003
FI	Lääkealan turvallisuus- ja kehittämiskeskus	085792
FR	Base de données publique des médicaments	64256891
GB	Medicines & Healthcare Products Regulatory Agency	173019
HK	Department of Health Drug Office	60588, 60589
IE	Health Products Regulatory Authority	65460, 76815
IL	מִשְׂרַד הַבְּרִיאוּת	6726
IT	Agenzia del Farmaco	040108019, 040108021, 040108033
LT	Valstybinė vaistų kontrolės tarnyba	1055468, 1055469, 1055470
NL	Z-Index G-Standaard	15654486
NL	Z-Index G-Standaard, PRK	96261
NZ	Medicines and Medical Devices Safety Authority	14646
PL	Rejestru Produktów Leczniczych	100221991
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W55639001, W55639003, W55639004
SG	Health Sciences Authority	14024P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699862950251
US	FDA, National Drug Code	55513-710
ZA	Health Products Regulatory Authority	54/30.1/0205