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

Version Date Safety Concerns Comment  Cerebrovascular adverse effects in elderly patients  Cerebrovascular adverse effects in nonelderly patients  Serotonin syndrome 

Version Date Safety Concerns Comment cholesterol, increased triglycerides, or decreased HDLs • Hyperglycemia and diabetes mellitus • Metabolic risk factors 1.2 02/03/2016 Important

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

Risk Management Plan v.2.1 Omeprazole Version Date Safety Concerns Comment 2.1 20 Nov 2017 Updated risks: Identified risks:  Severe hypomagnesemia  Risk of hypersensitivity

None of the above studies are conditions of the marketing authorisation VI.2.7 Summary of Changes to the Risk Management Plan Over Time Table 71: Major Changes to the Risk Management

Important potential risks Risk What is known Off-label use None Urinary tract infection None Missing information Risk What is known Interaction with other drugs used to