Canada 15th 2014 23rd April 2015 Rosiver (ivermectin) cream, 1% is indicated for the topical treatment of inflammatory lesions (papules and pustules) of rosacea in adults 18 years of age or older. Russia 1 August 2014 MAA Withdrawal Resubmission on Pending 14 September 2015 Colombia 5 September 2014 Pending Soolantra is indicated for the cutaneous Africa 3 October 2014 Pending treatment of inflammatory Chile 10 November 6 May 2015 lesions of rosacea 2014 in adult patients. Mexico 27 February 2015 Pending Argentina 7 April 2015 Pending Brazil 14 April 2015 Pending Switzerland 17 September 2015 Pending Soolantra is indicated for the topical treatment of inflammatory lesions of moderate to severe (papulopustular) rosacea (Investigator Global Assessment Grade 3 and 4) in adult patients Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings Drug substance (active ingredient) The drug substance, ivermectin is a semi synthetic broad spectrum antiparasitic drug derived from the Streptomyces avermitilis metabolite, traditionally used ‘avermectin’,
Canada 15th 2014 23rd April 2015 Rosiver (ivermectin) cream, 1% is indicated for the topical treatment of inflammatory lesions (papules and pustules) of rosacea in adults 18 years of age or older. Russia 1 August 2014 Resubmission on 14 September 2015 MAA Withdrawal Pending Colombia 5 September 2014 Pending Soolantra is indicated for the cutaneous treatment of inflammatory lesions of rosacea in adult patients. Africa 3 October 2014 Pending Chile 10 November 2014 6 May 2015 Mexico 27 February 2015 Pending Argentina 7 April 2015 Pending Brazil 14 April 2015 Pending Switzerland 17 September 2015 Pending Soolantra is indicated for the topical treatment of inflammatory lesions of moderate to severe (papulopustular) rosacea (Investigator Global Assessment Grade 3 and 4) in adult patients Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings Drug substance (active ingredient) The drug substance, ivermectin is a semi synthetic broad spectrum antiparasitic drug derived from the Streptomyces avermitilis metabolite, ‘avermectin’, traditionally used