European Union Submitted 22 November Jinarc is indicated to slow 2013 the progression of cyst development and renal Approved 27 May 2015 insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease United States of America Submitted 1 March 2013 Canada Submitted 27 March 2014 JinarcTM (tolvaptan) is indicated to slow the Approved 25 February progression of kidney 2015 enlargement in patients with autosomal dominant polycystic kidney disease (ADPKD). In ADPKD, kidney enlargement reflects renal cyst burden. Switzerland Submitted 3 October 2014 Same as EU Approved 21 2016 Japan Submitted 30 May 2013 Suppression of progression Approved 24 March 2014 of autosomal dominant polycystic kidney disease (ADPKD) in patients with increased kidney volume and a rapid rate of increase Republic of Korea Submitted 30 June 2015 Same as EU Approved 1 December 2015 Product Information The Product Information (PI) approved with the submission is described in this AusPAR can be found as Attachment 1. For the most recent PI, please refer to the TGA website at < >. II. Registration timeline Table 2: Registration timeline Description Date Submission dossier accepted and 1st round evaluation commenced 29 February 2016 1st evaluation completed 14 August 2016
European Union Submitted 22 November 2013 Approved 27 May 2015 Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease United States of America Submitted 1 March 2013 Canada Submitted 27 March 2014 Approved 25 February 2015 JinarcTM (tolvaptan) is indicated to slow the progression of kidney enlargement in patients with autosomal dominant polycystic kidney disease (ADPKD). In ADPKD, kidney enlargement reflects renal cyst burden. Switzerland Submitted 3 October 2014 Approved 21 2016 Same as EU Japan Submitted 30 May 2013 Approved 24 March 2014 Suppression of progression of autosomal dominant polycystic kidney disease (ADPKD) in patients with increased kidney volume and a rapid rate of increase Republic of Korea Submitted 30 June 2015 Approved 1 December 2015 Same as EU Product Information The Product Information (PI) approved with the submission is described in this AusPAR can be found as Attachment 1. For the most recent PI, please refer to the TGA website at < >. II. Registration timeline Table 2: Registration timeline Description Date Submission dossier accepted and 1st round evaluation commenced 29 February 2016 1st evaluation completed 14 August 2016
auspar-tolvaptan-180209.docx