Canada NA NA New Zealand Submitted 24 November Same as EU 2014 Singapore Submitted 26 2014 Same as EU Approved 6 October 2015 Switzerland Submitted 4 June 2009 Same as EU Approved 13 April 2010 Australia Submitted 8 December Ranexa is indicated for the treatment of 2009 chronic angina. (500 mg and 1000 mg strengths applied for only). Withdrawn by sponsor (Gilead Sciences in Sponsor unable to provide a full and 2011) complete response in the timeframe required, in relation to the impurity method and method validation. Taiwan Submitted 10 February Add-on therapy for the symptomatic 2014 treatment of patients with stable angina pectoris who are inadequately Withdrawn by the sponsor controlled or intolerant to first-line Sponsor unable to provide antianginal therapies (such as enough efficacy and safety blockers and/or calcium antagonists). data on population Product Information The Product Information (PI) approved with the submission which 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 for submission PM-2015-00423-1-3 Description Date Submission dossier accepted and 1st round evaluation 29 May 2015 commenced 1st round evaluation completed 2 November 2015 Sponsor provides responses on questions raised in 1st round 4 January 2016 evaluation 2nd round evaluation completed 26 February 2016 Delegate’s overall risk-benefit assessment and request for 2 March 2016 Advisory Committee advice
Canada NA NA New Zealand Submitted 24 November 2014 Same as EU Singapore Submitted 26 2014 Approved 6 October 2015 Same as EU Switzerland Submitted 4 June 2009 Approved 13 April 2010 Same as EU Australia Submitted 8 December 2009 Withdrawn by sponsor (Gilead Sciences in Ranexa is indicated for the treatment of chronic angina. (500 mg and 1000 mg strengths applied for only). Sponsor unable to provide a full and complete response in the timeframe required, in relation to the impurity method and method validation. Taiwan Submitted 10 February 2014 Withdrawn by the sponsor Sponsor unable to provide enough efficacy and safety data on population Add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as and/or calcium antagonists). Product Information The Product Information (PI) approved with the submission which 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 for submission PM-2015-00423-1-3 Description Date Submission dossier accepted and 1st round evaluation commenced 29 May 2015 1st round evaluation completed 2 November 2015 Sponsor provides responses on questions raised in 1st round evaluation 4 January 2016 2nd round evaluation completed 26 February 2016 Delegate’s overall risk-benefit assessment and request for Advisory Committee advice 2 March 2016 blockers 2011)
auspar-ranolazine-180220.docx