PAR Alendronic acid 70 mg Tablets
UK/H/1921/01/DC
Public Assessment Report Decentralised Procedure
Alendronic acid 70 mg Tablets UK/H/1921/01/DC UK licence no: PL 08553/0358 Dr. Reddy's Laboratories (UK) Limited
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PAR Alendronic acid 70 mg Tablets
UK/H/1921/01/DC
LAY SUMMARY
The Medicines and Healthcare products Regulatory Agency (MHRA) granted Dr Reddy's Laboratories (UK) Limited a Marketing Authorisation (licence) for the medicinal product Alendronic acid 70 mg Tablets (PL 08553/0358) on 15th October 2009. This is a prescriptiononly medicine (POM) for the treatment of postmenopausal osteoporosis. Alendronic acid 70 mg Tablets contain the active ingredient, alendronate sodium trihydrate. Following menopause, the cells that break down the bone (osteoclasts) may become more active than those that stimulate the manufacture of new bone (osteoblasts) and, as a result, loss of bone density and osteoporosis can occur. Alendronate sodium trihydrate can restore the osteoclast-to-osteoblast balance by blocking osteoclasts, thus preventing loss of bone mass and helping to rebuild lost bone. No new or unexpected safety concerns arose from these applications and it was therefore judged that the benefits of taking Alendronic acid 70 mg Tablets outweigh the risks; hence a Marketing Authorisation has been granted.
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PAR Alendronic acid 70 mg Tablets
UK/H/1921/01/DC
TABLE OF CONTENTS
Module 1: Information about initial procedure Module 2: Summary of Product Characteristics Module 3: Patient Information Leaflet Module 4: Labelling Module 5: Scientific Discussion I Introduction II About the product III Scientific overview and discussion III.1 Quality aspects III.2 Pre-clinical aspects III.3 Clinical aspects IV Overall conclusion and benefit-risk assessment Module 6: Steps taken after initial procedure Page 4 Page 5 Page 13 Page 15 Page 18 Page 18 Page 19 Page 20 Page 20 Page 22 Page 22 Page 29 Page 30

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