ACTONEL

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

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 more about Risedronic acid

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ACTONEL Film-coated tablet	MPI, EU: SmPC	Marketing Authorisation Holder

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	2191H, 4443W, 8481J, 8482K, 8972F, 9391G
BR	Câmara de Regulação do Mercado de Medicamentos	502800104119314, 502800105115312, 502813060065205, 502813060065305, 576720090088717, 576720090088817, 576720090088917
CA	Health Products and Food Branch	02246896, 02316838, 02370417
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	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	63207, 63208, 65167, 69696, 81940
FR	Base de données publique des médicaments	60399454, 64144419, 64392560, 65740030, 69716824
GB	Medicines & Healthcare Products Regulatory Agency	132111, 138234, 140396, 140398, 180498, 19160, 198638, 40287
HK	Department of Health Drug Office	50537, 60147
HR	Agencija za lijekove i medicinske proizvode	HR-H-350046678, HR-H-648885316
IE	Health Products Regulatory Authority	10325, 10505, 10581, 10603, 10716, 10894
IT	Agenzia del Farmaco	034568030, 034568105, 034568143
JP	医薬品医療機器総合機構	3999019F1026, 3999019F2022, 3999019F3029
NL	Z-Index G-Standaard, PRK	59064, 68888, 85995
NZ	Medicines and Medical Devices Safety Authority	10198, 8810
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W66214001, W66214002, W66214003, W66214004, W66497001, W66497002, W66497003, W66497004, W66497005, W66497006, W66935001, W66935002, W66935003, W66935004, W66935005, W66935006
SG	Health Sciences Authority	11569P, 12284P, 13948P
US	FDA, National Drug Code	0430-0472, 0430-0478
ZA	Health Products Regulatory Authority	34/3.2/0114, 34/3.2/0115, 37/3.2/0129, 42/3.2/0452, 43/3.2/0131