EU (Centralised Submitted: 17 November 2016 is indicated for the ‘RoActemra procedure). treatment of Giant Cell Arteritis Positive CHMP opinion: 20 July 2017 (GCA) in adult patients.’ Rapporteur: EU registration: 18 September 2017 Germany; Co-rapporteur: Hungary. USA Submitted: 22 November 2016 patients with giant cell ‘Adult arteritis.’ Approved: 22 May 2017 Breakthrough Therapy Designation was granted by FDA for Actemra for giant cell arteritis. The application was evaluated under Priority Review. Canada Submitted: 30 2017 Actemra is indicated for the treatment of giant cell arteritis Approved: 27 October 2017 (GCA) in adult patients. New Zealand Submitted: 9 December 2016 is indicated for the ‘Actemra treatment of giant cell arteritis Approved: 1 June 2017 (GCA) in adult patients.’ Switzerland Submitted: 6 January 2017 Under evaluation 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-2016-03548-1-4 Description Date Submission dossier accepted and 1st round evaluation commenced 3 January 2017 First round evaluation completed 29 May 2017 Sponsor provides responses on questions raised in round 3 July 2017 evaluation Second round evaluation completed 9 August 2017 Request for Advisory Committee advice and/or Delegate’s Overview 4 September 2017
EU (Centralised procedure). Rapporteur: Germany; Co-rapporteur: Hungary. Submitted: 17 November 2016 Positive CHMP opinion: 20 July 2017 EU registration: 18 September 2017 ‘RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.’ USA Submitted: 22 November 2016 Approved: 22 May 2017 Breakthrough Therapy Designation was granted by FDA for Actemra for giant cell arteritis. The application was evaluated under Priority Review. ‘Adult patients with giant cell arteritis.’ Canada Submitted: 30 2017 Approved: 27 October 2017 Actemra is indicated for the treatment of giant cell arteritis (GCA) in adult patients. New Zealand Submitted: 9 December 2016 Approved: 1 June 2017 ‘Actemra is indicated for the treatment of giant cell arteritis (GCA) in adult patients.’ Switzerland Submitted: 6 January 2017 Under evaluation 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-2016-03548-1-4 Description Date Submission dossier accepted and 1st round evaluation commenced 3 January 2017 First round evaluation completed 29 May 2017 Sponsor provides responses on questions raised in round evaluation 3 July 2017 Second round evaluation completed 9 August 2017 Request for Advisory Committee advice and/or Delegate’s Overview 4 September 2017
auspar-tocilizumab-180613.docx