Table 1. Overseas regulatory status. Procedure Country Date of Date of Proposed submission Approval indication USA 14 Dec 2011 14 Jan 2013 Induction of (under the name remission in Uceris) patients with active, mild to moderate ulcerative colitis (UC). Netherlands (RMS) 30 May 2011 28 Feb 2013 Induction of remission in adult European Austria Apr 2014 17 Dec 2014 patients with active, (EU) via Mutual Belgium 26 Nov 2014 mild to moderate Recognition Bulgaria Ongoing UC, where 5-ASA Procedure Croatia 09 Dec 2014 salicylic acid) (MRP) Cyprus Ongoing treatment is not Czech 14 Jan 2015 sufficient. Republic Estonia 31 Mar 2015 Finland 12 Dec 2014 Germany 13 January 2015 Greece Ongoing Hungary 19 November 2014 Iceland 22 January 2015 Ireland 05 December 2014 Italy Ongoing Latvia 27 January 2015 Lithuania 23 December 2014 Luxembourg 01 April 2015 Ongoing Norway 27 November 2014 Poland 23 January 2015 Portugal 01 December 2014 Romania 19 February 2015 Slovakia 19 February 2014 Slovenia 18 March 2015 Spain Ongoing Sweden 04 January 2015 United Kingdom 19 November 2014 EU via DCP Rejected August Induction of (submitted in 15 2012 remission in trial countries)* patients with active, mild, to moderate UC. Canada April 2015 Ongoing Induction of remission in adult Brazil 05 November Ongoing patients with active, 2014 mild, to moderate Israel 08 April 2014 Ongoing UC. Jordan 23 July 2014 Ongoing Kuwait 07 December Ongoing 2014
Table 1. Overseas regulatory status. Procedure Country Date of submission Date of Approval Proposed indication USA (under the name Uceris) 14 Dec 2011 14 Jan 2013 Induction of remission in patients with active, mild to moderate ulcerative colitis (UC). Netherlands (RMS) 30 May 2011 28 Feb 2013 Induction of remission in adult patients with active, mild to moderate UC, where 5-ASA salicylic acid) treatment is not sufficient. European (EU) via Mutual Recognition Procedure (MRP) Austria Apr 2014 17 Dec 2014 Belgium 26 Nov 2014 Bulgaria Ongoing Croatia 09 Dec 2014 Cyprus Ongoing Czech Republic 14 Jan 2015 Estonia 31 Mar 2015 Finland 12 Dec 2014 Germany 13 January 2015 Greece Ongoing Hungary 19 November 2014 Iceland 22 January 2015 Ireland 05 December 2014 Italy Ongoing Latvia 27 January 2015 Lithuania 23 December 2014 Luxembourg 01 April 2015 Ongoing Norway 27 November 2014 Poland 23 January 2015 Portugal 01 December 2014 Romania 19 February 2015 Slovakia 19 February 2014 Slovenia 18 March 2015 Spain Ongoing Sweden 04 January 2015 United Kingdom 19 November 2014 EU via DCP (submitted in 15 countries)* Rejected August 2012 Induction of remission in patients with active, mild, to moderate UC. Canada April 2015 Ongoing Induction of remission in adult patients with active, mild, to moderate UC. Brazil 05 November 2014 Ongoing Israel 08 April 2014 Ongoing Jordan 23 July 2014 Ongoing Kuwait 07 December 2014 Ongoing trial
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