ACTONEL

Active ingredients

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

UNII OFG5EXG60L - RISEDRONATE SODIUM

Risedronic acid is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. The bone turnover is reduced while the osteoblast activity and bone mineralisation is preserved.

Read about Risedronic acid

Medication package inserts

Below package inserts are available for further reading:

Title
Type
Country
ACTONEL Film-coated tablet
Summary of Product Characteristics (SPC)
IE

Medicine classification

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

ATC code
Group title
Classification
M05BA07
Risedronic acid
M Musculo-skeletal system → M05 Drugs for treatment of bone diseases → M05B Drugs affecting bone structure and mineralization → M05BA Bisphosphonates
Discover more medicines within M05BA07

Authorization and marketing

This brand name is authorized in the following countries: Austria Australia Brazil Canada Cyprus Germany Spain France Hong Kong Ireland Italy Netherlands New Zealand Romania Singapore United Kingdom United States South Africa

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

Country
Identification scheme
Identifier(s)
AU
Pharmaceutical Benefits Scheme
Identifier(s): 2191H, 4443W, 8481J, 8482K, 8972F, 9391G
BR
Câmara de Regulação do Mercado de Medicamentos
Identifier(s): 502800104119314, 502800105115312, 502813060065205, 502813060065305, 576720090088717, 576720090088817, 576720090088917
CA
Health Products and Food Branch
Identifier(s): 02246896, 02316838, 02370417
DE
Bundesinstitut für Arzneimittel und Medizinprodukte
Identifier(s): 00096589, 00637022, 00637045, 01035650, 01035673, 01244572, 01888312, 02237717, 02649584, 03258302, 03390711, 03390763, 04015010, 05560034, 05904752, 05904769, 07210060, 07351168, 07351174, 07627044, 07631784, 10077512, 10263692, 13506669, 13506675
ES
Centro de información online de medicamentos de la AEMPS
Identifier(s): 63207, 63208, 65167, 69696, 81940
FR
Base de données publique des médicaments
Identifier(s): 60399454, 64144419, 64392560, 65740030, 69716824
GB
Medicines & Healthcare Products Regulatory Agency
Identifier(s): 132111, 138234, 140396, 140398, 180498, 19160, 198638, 40287
HK
Department of Health Drug Office
Identifier(s): 50537, 60147
IE
Health Products Regulatory Authority
Identifier(s): 10325, 10505, 10581, 10603, 10716, 10894
IT
Agenzia del Farmaco
Identifier(s): 034568030, 034568105, 034568143
NL
Z-Index G-Standaard, PRK
Identifier(s): 59064, 68888, 85995
NZ
Medicines and Medical Devices Safety Authority
Identifier(s): 10198, 8810
RO
Agenția Națională a Medicamentului și a Dispozitivelor Medicale
Identifier(s): W66214001, W66214002, W66214003, W66214004, W66497001, W66497002, W66497003, W66497004, W66497005, W66497006, W66935001, W66935002, W66935003, W66935004, W66935005, W66935006
SG
Health Sciences Authority
Identifier(s): 11569P, 12284P, 13948P
US
FDA, National Drug Code
Identifier(s): 0430-0472, 0430-0478
ZA
Health Products Regulatory Authority
Identifier(s): 34/3.2/0114, 34/3.2/0115, 37/3.2/0129, 42/3.2/0452, 43/3.2/0131