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Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended ALENDRONATE SODIUM
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Document Date: 2011-07-06 13:23:05

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File Size: 176,78 KB

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City

Alendronate / /

Company

AEs / /

Country

United States / United Kingdom / Czech Republic / /

Event

FDA Phase / /

IndustryTerm

pharmaceutical formulation / clinical study protocol / alendronate containing products / treatment of osteoporosis / parallel / medicinal products / food / /

MedicalCondition

chronic pain / glucocorticoid-induced osteoporosis / GI disorders / nephritis / limb deformity / postmenopausal osteoporosis / bone disease / pain / osteomalacia / osteoporosis / paediatric osteoporosis / Osteogenesis imperfecta / osteoclastic bone resorption / skeletal disorders / bone resorption / steroid-induced osteoporosis / disorders / /

MedicalTreatment

surgery / /

Organization

FDA / European Union / /

Person

Shirley Norton / /

Position

investigator / EXECUTIVE / /

Product

Fosamax / Dronal Tablets / ALENDRONATE SODIUM / Drugs affecting bone metabolism Bisphosphonate M05BA04 Tablets / alendronate / /

Technology

study Protocol / pharmacokinetics / radiation / crystallization / clinical study protocol / clinical studies Protocol / clinical adverse experience Protocol / /

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