is indicated in conjunction with ventilator support and other ‘VasoKINOX appropriate active substances for the treatment of: Newborn infants 34 gestation with hypoxic respiratory failure associated with ≥ clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation. Perioperative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 trial in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve left ventricular function and oxygenation by increasing the pulmonary flow.’ Product Information The Product Information (PI) approved with the submission which is described in this AusPAR can be found as Attachment 1. , please refer to the TGA website at <https://www.tga.gov.au/product-information-pi>. II. Registration Timeline Table 2: Registration timeline Description Date Submission dossier accepted and 1st round evaluation 31 2015 commenced 1st round evaluation completed 11 September 2015 Sponsor provides responses on questions raised in 1st round 31 October 2015 evaluation 2nd evaluation completed 30 November 2015 Delegate’s overall risk-benefit assessment and request for 4 January 2016 Advisory Committee advice Sponsor’s pre-Advisory Committee meeting response 18 January 2016 Advisory Committee meeting 26 February 2016 Registration decision 18 March 2016 Entry onto ARTG 16 January 2017 Number of TGA working days from submission dossier 197 acceptance to registration decision * * Target timeframe for standard applications: 220 working days
‘VasoKINOX is indicated in conjunction with ventilator support and other appropriate active substances for the treatment of: Newborn infants ≥ 34 gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation. Perioperative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve left ventricular function and oxygenation by increasing the pulmonary flow.’ Product Information The Product Information (PI) approved with the submission which is described in this AusPAR can be found as Attachment 1. , please refer to the TGA website at <https://www.tga.gov.au/product-information-pi>. II. Registration Timeline Table 2: Registration timeline Description Date Submission dossier accepted and 1st round evaluation commenced 31 2015 1st round evaluation completed 11 September 2015 Sponsor provides responses on questions raised in 1st round evaluation 31 October 2015 2nd evaluation completed 30 November 2015 Delegate’s overall risk-benefit assessment and request for Advisory Committee advice 4 January 2016 Sponsor’s pre-Advisory Committee meeting response 18 January 2016 Advisory Committee meeting 26 February 2016 Registration decision 18 March 2016 Entry onto ARTG 16 January 2017 Number of TGA working days from submission dossier acceptance to registration decision * 197 * Target timeframe for standard applications: 220 working days trial
auspar-nitric-oxide-180115.docx