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2015 Same as EU Switzerland Submitted 4 June 2009 Approved 13 April 2010 Same as EU Australia Submitted 8 December 2009 Withdrawn by sponsor (Gilead Sciences in Ranexa is indicated for the treatment of chronic angina.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 Taiwan Submitted 10 February 2014 Withdrawn by the sponsor Sponsor unable to provide enough efficacy and safety data on population Add-on therapy for the symptomatic treatment of patients with stable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)
-wording in the Patient Card Drug-drug interaction with immunosuppressants with a narrow therapeutic index metabolised by CYP3A4 (ciclosporin, tacrolimus, sirolimus, everolimus) -routine pharmacovigilance -special form to follow-up cases -IMS Disease Analyzer data will be collected for the analysis of medical disease sate and concomitant medications. -wording in the Patient Card Drug-drug PK interaction between ranolazine and metformin -routine pharmacovigilance Male infertility -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information Use in pregnant or lactating women and the paediatric population -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information Ethnicity other than Caucasian -routine pharmacovigilance: If ethnicity data is volunteered, these data will be collected and included in the individual case reports and PSURs Safety information for patients with moderate or severe hepatic impairment -routine pharmacovigilance Safety information for patients with severe and end-stage renal disease requiring dialysis -routine pharmacovigilance Drug-drug interactions with Ia and Class III antiarrhythmics except amiodarone -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information -wording in the Patient Alert Card Antihistamines (for example terfenadine, astemizole, mizolastine), certain antiarrhythmics (for example quinidine, disopyramide, procainamide), erythromycin, and tricyclic antidepressants (for example imipramine, doxepin, amitriptyline) -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information -wording in the Patient Alert Card Real-world safety information for drug-drug interactions with potent CYP3A4 inhibitors which may cause ranolazine plasma concentration increases -routine pharmacovigilance -IMS Disease Analyzer data will be collected for identifying this missing information -wording in the Patient Card