CoDiovan 160/25 mg Tablets: Oval, non-divisible, film-coated tablets measuring approximately 14.2 mm by 5.7 mm and 4.5 mm in thickness, (Calculations assume an oral dose of 320 mg/day valsartan in combination with 25
CoDiovan 160 mg/12.5 mg and Co-Diovan forte Filmtabletten 160 mg/25 mg were approved in Germany on 16 December 2002 and 9 February 2004, respectively. On 13 April 2007 the 320 mg/12.5 mg and 320 mg/25 mg strengths were registered. Co-Diovan has been approved via MRP (SE/H/0565) in all CMSs involved in this procedure.Characteristics The reference product used in the bio-equivalence study is Co Diovan Forte tabletsmarketed by Novartis Pharma GmbHinGermany II. QUALITY ASPECTS II.1 Introduction Valsartan/Hydrochlorothiazide CT, film-coated tablets containing 320 of valsartan and 12.5 mg of hydrochlorothiazide or 320 of valsartan and 25 mg of wx9B. 487 137 460 188 337 165 245 12 488