Table 1. Overseas regulatory status. Country/Region Date submitted or Approval date Proposed indication intend to submit United States of 20 December 19 December Soolantra cream is America 2013 2014 indicated for the topical treatment of inflammatory lesions of rosacea. Europe 22 March 2015 Soolantra is indicated for the procedure) topical treatment of inflammatory lesions of rosacea Austria, Estonia, 8 April 2014 AT: 02 June 2015 (papulo-pustular) Germany, Malta ET: 08 June 2015 in adult patients. and Spain DE: 29 April 15 Malta: 02 April 2015 ES : 02 June 2015 Belgium, Bulgaria, 9 April 2014 BE: 03 April 2015 Czech Republic, BG : 10 June 2015 Denmark, Finland, France, Hungary, CZ : 13 May 2015 Ireland, Latvia, DK : 22 April 2015 Luxembourg, Lithuania, Poland, FI: 26 June 2015 Portugal, Romania, FR: 21 July 2015 Slovakia and United Kingdom HU: 14 April 2015 IE: 24 April 2015 LV: 13 July 2015 LU: 01 July 2015 LT: 13 may 2015 PL: 23 July 2015 PT: 08 April 2015 RO: 26 May 2015 SK: 11 june 2015 UK: 17 2015 Cyprus, Greece, 10 April 2014 Cyprus: pending Iceland, Italy, The Greece: pending Netherlands, Norway and IS: 29 April 2015 Sweden IT: 13 July 2015 NL: 04 may 2015 NO: 23 April 2015 SE: 22 April 2015
Table 1. Overseas regulatory status. Country/Region Date submitted or intend to submit Approval date Proposed indication United States of America 20 December 2013 19 December 2014 Soolantra cream is indicated for the topical treatment of inflammatory lesions of rosacea. Europe procedure) 22 March 2015 Soolantra is indicated for the topical treatment of inflammatory lesions of rosacea (papulo-pustular) in adult patients. Austria, Estonia, Germany, Malta and Spain 8 April 2014 AT: 02 June 2015 ET: 08 June 2015 DE: 29 April 15 Malta: 02 April 2015 ES : 02 June 2015 Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Latvia, Luxembourg, Lithuania, Poland, Portugal, Romania, Slovakia and United Kingdom 9 April 2014 BE: 03 April 2015 BG : 10 June 2015 CZ : 13 May 2015 DK : 22 April 2015 FI: 26 June 2015 FR: 21 July 2015 HU: 14 April 2015 IE: 24 April 2015 LV: 13 July 2015 LU: 01 July 2015 LT: 13 may 2015 PL: 23 July 2015 PT: 08 April 2015 RO: 26 May 2015 SK: 11 june 2015 UK: 17 2015 Cyprus, Greece, Iceland, Italy, The Netherlands, Norway and Sweden 10 April 2014 Cyprus: pending Greece: pending IS: 29 April 2015 IT: 13 July 2015 NL: 04 may 2015 NO: 23 April 2015 SE: 22 April 2015
auspar-ivermectin-151209.docx