Weighted mean percent sputum eosinophil levels (Day 0 to 84 or last day 84) with available eosinophil data prior to Day 84) w/v (%) Weight/Volume (Percentage) I. Introduction to product submission Submission details New biological entity Type of submission: Decision: Approved Date of decision: 25 January 2016 Date of entry onto ARTG 02 February 2016 Active ingredient(s): Mepolizumab (rch) Product name(s): Nucala GlaxoSmithKline Australia Pty Ltd (GSK) Sponsor’s name and address: PO Box 18095 Melbourne VIC 8003, Australia Dose form(s): Powder for injection 100 mg Strength(s): Container(s): Vial Pack size(s): One single-use vial per pack (WFI not included) Approved therapeutic use: Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in patients aged 12 years and over see Clinical Trials) of administration: Subcutaneous (SC) injection Dosage: 100 mg every 4 weeks ARTG number: 232028 Product background This AusPAR describes the application by the sponsor to register a new biological entity, mepolizumab (Nucala) for the following proposed indication: Nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over identified by either a blood eosinophil count 150 cells/L at ≥
84) Weighted mean percent sputum eosinophil levels (Day 0 to 84 or last day with available eosinophil data prior to Day 84) w/v (%) Weight/Volume (Percentage) I. Introduction to product submission Submission details Type of submission: New biological entity Decision: Approved Date of decision: 25 January 2016 Date of entry onto ARTG 02 February 2016 Active ingredient(s): Mepolizumab (rch) Product name(s): Nucala Sponsor’s name and address: GlaxoSmithKline Australia Pty Ltd (GSK) PO Box 18095 Melbourne VIC 8003, Australia Dose form(s): Powder for injection Strength(s): 100 mg Container(s): Vial Pack size(s): One single-use vial per pack (WFI not included) Approved therapeutic use: Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in patients aged 12 years and over see Clinical Trials) of administration: Subcutaneous (SC) injection Dosage: 100 mg every 4 weeks ARTG number: 232028 Product background This AusPAR describes the application by the sponsor to register a new biological entity, mepolizumab (Nucala) for the following proposed indication: Nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over identified by either a blood eosinophil count ≥ 150 cells/L at
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