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
Prospective cohort into the prescribing of metformin + liraglutide in combination with insulin as add-on and the risk of neoplasms in the GPRD Protocol not available Protocol addendum available Potential risk of malignant neoplasms following treatment with combination of insulin detemir + liraglutide + metformin No protocol available 31/12/2012 report) Diabetes Pregnancy Registry An international cohort study to evaluate the safety of treatment with Levemir® (insulin detemir) in pregnant women with diabetes mellitus (NN304-4016) Protocol available Unexpected safety issues arising from exposure to insulin detemir of pregnant women and the safety of children exposed in utero Primary objective: To compare the proportion of pregnancies in pregnant women treated with Levemir® to pregnant women treated with other basal insulin regimens which results in none of the following events: Major congenital anomalies Perinatal death Neonatal death Spontaneous abortion Secondary objectives: Multiple (see protocol) Q4, 2019 (LPLV) A summary analysis based on descriptive statistics will be provided at the end of the LEADER trial. (EX2211-3748) Potential risk of malignant neoplasms following treatment with combination of insulin detemir + liraglutide + metformin LEADER trial LPLV 19/01/2016 Meta analysis of selected clinical trials Cardiovascular and cerebrovascular events Aligned with the post-approval PSURs trial