AusPAR: Clobetasol propionate - Therapeutic Goods Administration

Therapeutic Goods AdministrationOPR reviewer’s comments in regard to the pharmacovigilance plan and theappropriateness of milestonesIt was considered that routine pharmacovigilance activities are satisfactory to monitor theImportant identified risk: Adrenal disorders: adrenal suppression/Cushing’s syndrome.Risk minimisation activitiesNo additional risk minimisation activities are planned for Clobex shampoo.OPR reviewer commentRoutine risk minimisation activities 16 were considered sufficient to monitor the safetyconcerns associated with Clobex shampoo.In regard to the proposed routine risk minimisation activities, the draft PI and consumermedicine documents are considered satisfactory. However, it was recommended that thesponsor include advice in the Dosage and Administration section of the PI on therecommended “off treatment” duration between treatment courses.Summary of recommendationsThe OPR provided these recommendations in the context that the submitted RMP issupportive to the application;It was recommended that the Delegate:• Implement RMP Version 2, dated 11 May 2012 including the sponsor’s response to theTGA request for information/documents (Section 31 request) and any future updatesas a condition of registration.It was recommended to the Delegate that the sponsor:• Include advice in the Dosage and Administration section of the PI on the recommended“off treatment” duration between treatment courses.VI. Overall conclusion and risk/benefit assessmentThe submission was summarised in the following Delegate’s overview andrecommendations:QualityThe evaluator states that “most” chemistry and quality control issues have been resolved.Based on the original data set, the evaluator initially recommended a shelf life of threemonths only. This was because there were some outstanding manufacturing and testingissues which were to be resolved in December 2012, based on additional testing that wasbeing conducted by Galderma. These tests were to reliably demonstrate the absence ofimpurities from the finished product. The results of these tests would enable therecommendation of a more realistic shelf life for this product. [The sponsor is to submitthese data once registration occurs, to extend the shelf life of this product]. The open shelflife is 4 weeks.• Submission of PSURs;• Meeting other local regulatory agency requirements.16 Routine risk minimisation activities may be limited to ensuring that suitable warnings are included inthe product information or by careful use of labelling and packaging.AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5Final 22 May 2013Page 31 of 45