VI.2 Elements for a Public Summary

Summary EU-Risk Management Plan NL/H/3457/001-002/DC - Palonosetron Fresenius Kabi VI.2 ELEMENTS FOR A PUBLIC SUMMARY VI.2.1 OVERVIEW OF DISEASE EPIDEMIOLOGY Acute nausea

Page 14 of 37 Part VI: Summary of activities in the risk management plan by product VI.1 Elements for summary tables in the EPAR VI.1.1 Summary table of Safety concerns Summary

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

VI.2.7 Summary of changes to the Risk Management Plan over time Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 1.0 Submitted Dec-2012

VI.2.7 Summary of changes to the Risk Management Plan over time Table 4: Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 1.0 03 August 2012 No

VI.2.7 Summary of changes to the Risk Management Plan over time Table 15: Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 1.0 20 August 2007

VI.2.7 Summary of changes to the Risk Management Plan over time Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 1.0 16-04- 2014

VI.2.7 Summary of changes to the Risk Management Plan over time Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 1.0 07-03-2013 sing-off date,