This submission does not involve any change to the currently approved indication, population, drug formulation or dosage form. Regulatory status The product received initial ARTG Registration on 9 September 2011. Applications for have been submitted or approved in several jurisdictions The sponsor has provided four tables to indicate the overseas registration status in regard to the four changes proposed for the Australian market (listed in Table 1). Table 1: International regulatory status Country Use of Paediatric Use of Alignment Levemir with safety data for Levemir in with the liraglutide Type 1 pregnancy sponsor’s diabetes CCDS European Union Approval: Approval Date Approval Date: Approval Date: (EU) 2011 14-10-2011 19-12-2011 19-12-2011 Levemir as an Indications: Indications: Indications: add-on to Victoza. Treatment of Treatment of Treatment of diabetes mellitus diabetes mellitus diabetes mellitus Indications: in adults, in adults, in adults, Treatment of adolescents and adolescents and adolescents and diabetes mellitus children aged 2 children aged 2 children aged 2 in adults, years and above. years and above. years and above. adolescents and children aged 2 years and above. United States of Approval Date: Approval Date: Approval Date: Approval Date: America 27-14-2012 18-05-2012 29-03-2012 18-04-2012 Levemir in Indications and Indications and Indications and combination with usage: Levemir is usage: Levemir is Levemir is GLP-1. indicated to indicated to indicated to improved improved improved Indications and glycaemic control glycaemic control glycaemic control usage: Levemir is in adults and in adults and in adults and indicated to children with children with children with improved diabetes mellitus. diabetes mellitus. diabetes mellitus. glycaemic control in adults and children with diabetes mellitus. Canada N/A N/A N/A N/A Switzerland N/A Approval Date: N/A Approval Date: 28-04-2011 18/04/2012 Indications: Indications: Diabetes mellitus Diabetes mellitus in adults, in adults, adolescents and adolescents and children age 2 children age 2 trial if insulin years if insulin treatment is treatment is necessary. necessary.
This submission does not involve any change to the currently approved indication, population, drug formulation or dosage form. Regulatory status The product received initial ARTG Registration on 9 September 2011. Applications for have been submitted or approved in several jurisdictions The sponsor has provided four tables to indicate the overseas registration status in regard to the four changes proposed for the Australian market (listed in Table 1). Table 1: International regulatory status Country Use of Levemir with liraglutide Paediatric safety data for Type 1 diabetes Use of Levemir in pregnancy Alignment with the sponsor’s CCDS European Union (EU) Approval: Levemir as an add-on to Victoza. Indications: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. Approval Date 14-10-2011 Indications: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. Approval Date: 19-12-2011 Indications: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. Approval Date: 19-12-2011 Indications: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. United States of America Approval Date: 27-14-2012 Levemir in combination with GLP-1. Indications and usage: Levemir is indicated to improved glycaemic control in adults and children with diabetes mellitus. Approval Date: 18-05-2012 Indications and usage: Levemir is indicated to improved glycaemic control in adults and children with diabetes mellitus. Approval Date: 29-03-2012 Indications and usage: Levemir is indicated to improved glycaemic control in adults and children with diabetes mellitus. Approval Date: 18-04-2012 Indications and Levemir is indicated to improved glycaemic control in adults and children with diabetes mellitus. Canada N/A N/A N/A N/A Switzerland N/A Approval Date: 28-04-2011 Indications: Diabetes mellitus in adults, adolescents and children age 2 if insulin treatment is necessary. N/A Approval Date: 18/04/2012 Indications: Diabetes mellitus in adults, adolescents and children age 2 years if insulin treatment is necessary. trial 2011
auspar-insulin-detemir-rys-140328.docx