PDF VI.2 Elements for a Public Summary

Study/activity including study number Objectives Safety concerns /efficacy issue addressed Status Planned date for submission of interim and final results

EU-Risk Management Plan for Gliclatim, Stada VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Coma due to too low blood sugar

7.2.4 Part VI.2.4 Summary of safety concerns Table 7-5 Important identified risks Risk What is known Preventability Use in newborns and children younger than 2 years Use in

VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Slow, weak breathing Respiratory depression Slow, weak breathing is well- known

Major Changes to the Risk Management Plan Over Time Version Date Safety Concerns Comment 2.0 19 April 2017 Hypersensitivity and anaphylactic reactions upgraded to important

N/A Important potential risks Safety concern Summary of Routine Risk Minimisation Activities Summary of Additional Risk Minimisation Activities Severe skin and severe allergic

VI.2.7 Summary of changes to the Risk Management Plan over time Version Date dd- mm-yyyy Safety Concerns Comment 01 16-04-2015 Important identified risks  Hypersensitivity to

2.7 Summary of changes to the Risk Management Plan over time Version Date Changes compared to previous version 2.0 DLP 23 Dec 2013 Part II: Missing information "Use in adolescent