PDF VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology

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

VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Suppressed development and division of bone marrow cells Myelosuppression Given

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

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.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Thrombotic and embolic events inc., pulmonary embolism and stroke Tranexamic acid

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

Summary EU‐Risk Management Plan Ibandronsyre Fresenius Kabi ‐ PT/H/1244/001/DC VI.2 Elements for a Public Summary VI.2.1 Overview of Disease Epidemiology Ibandronic Acid

VI.2.7 Summary of changes to the Risk Management Plan over time Version Date Safety concerns Comment 10.02.2017 Version 01  Version 01 Important identified risks  Fatal