The sponsor’s proposed application of routine risk The sponsor this comment. N/A minimisation activities would appear to be reasonable and therefore acceptable. In regard to the proposed routine risk minimisation The sponsor notes this comment. N/A activities, the draft PI document is considered satisfactory. In regard to the proposed routine risk minimisation The sponsor this comment. N/A activities, the draft Consumer Medicine Information (CMI) document is considered satisfactory.
The sponsor’s proposed application of routine risk minimisation activities would appear to be reasonable and therefore acceptable. The sponsor this comment. N/A In regard to the proposed routine risk minimisation activities, the draft PI document is considered satisfactory. The sponsor notes this comment. N/A In regard to the proposed routine risk minimisation activities, the draft Consumer Medicine Information (CMI) document is considered satisfactory. The sponsor this comment. N/A
auspar-mirabegron-140109.docx