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UK Public Assessment Report

UKPAR Valsartan 40mg, 80mg, & 160mg film-coated tablets PL 20092/0045-7 1 Valsartan 40mg film-coated tablets Valsartan 80mg film-coated tablets Valsartan 160mg film-coated tablets (valsartan) PL 20092/0045-7 UK Public Assessment Report TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for Assessment Page 15 Steps taken after authorisation Page 16 Summary of Product Characteristics Page 17 Product Information Leaflet Page 29 Labelling Page 35 UKPAR Valsartan 40mg, 80mg, & 160mg film-coated tablets PL 20092/0045-7 2 Valsartan 40mg, 80mg and 160mg film-coated tablets (valsartan) PL 20092/0045-7 LAY SUMMARY The Medicines and Healthcare products Regulatory Agency (MHRA) granted Lupin (Europe) Limited Marketing Authorisations (licences) for the medicinal products Valsartan 40mg, 80mg and 160mg film-coated tablets (PL 20092/0045-7) on 25th February 2010.

UKPAR Valsartan 40mg, 80mg, & 160mg film-coated tablets PL 20092/0045-7 2 Valsartan 40mg, 80mg and 160mg film-coated tablets (valsartan) PL 20092/0045-7

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