VI.2

Table 41: Major changes to the Risk Management Plan over time Version Date Safety concerns Comment Version 1.0 May 2012 Important identified risks Hypersensitivity/anaphylactic

Studies which are a condition of the marketing authorization None Summary of changes to the Risk Management Plan over time Table 27 Major changes to the Risk Management Plan over time

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

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

Part VI: Summary of the risk management plan by product VI.1 Elements for summary tables in the EPAR VI.1.1 Summary table of Safety concerns Summary of safety concerns Important

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

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