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

Active ingredients

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

1 Risedronic acid

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 Information Source Document Type  
ACTONEL Film-coated tablet Marketing Authorisation Holder 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
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 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): 2191H, 4443W, 8481J, 8482K, 8972F, 9391G
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 502800104119314, 502800105115312, 502813060065205, 502813060065305, 576720090088717, 576720090088817, 576720090088917
Country: CA Health Products and Food Branch Identifier(s): 02246896, 02316838, 02370417
Country: 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
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 63207, 63208, 65167, 69696, 81940
Country: FR Base de données publique des médicaments Identifier(s): 60399454, 64144419, 64392560, 65740030, 69716824
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 132111, 138234, 140396, 140398, 180498, 19160, 198638, 40287
Country: HK Department of Health Drug Office Identifier(s): 50537, 60147
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-350046678, HR-H-648885316
Country: IE Health Products Regulatory Authority Identifier(s): 10325, 10505, 10581, 10603, 10716, 10894
Country: IT Agenzia del Farmaco Identifier(s): 034568030, 034568105, 034568143
Country: JP 医薬品医療機器総合機構 Identifier(s): 3999019F1026, 3999019F2022, 3999019F3029
Country: NL Z-Index G-Standaard, PRK Identifier(s): 59064, 68888, 85995
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 10198, 8810
Country: 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
Country: SG Health Sciences Authority Identifier(s): 11569P, 12284P, 13948P
Country: US FDA, National Drug Code Identifier(s): 0430-0472, 0430-0478
Country: 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

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