ACTONEL

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 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	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