VI.2 Elements for a Public 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

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

RFX200/2015/3.0 Rifaximin 200 mg in TD Page 87/89 CONFIDENTIAL VI.2.7 Summary of changes to the Risk Management Plan over time Major changes to the Risk Management Plan over

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 3.0 At time of

VI.2.6 Summary of changes to the Risk Management Plan over time Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 1.2 11.9.2014 Important

ORION PHARMAp Part VI: Summary of activities in the risk management plan by product Page 44/74 Important potential risks Risk What is known Including reason why it is considered a

VI.2.2 Summary of treatment benefits belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder GAD in adults.. Peripheral and central

VI.2.7 Summary of Changes to the Risk Management Plan over Time Table 72: Major Changes to the Risk Management Plan over Time Version Date Safety Concerns Comment 3.2 12 Nov