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

- Upgrade of “Use in pregnant women” from missing information to important potential risk “Safety in pregnant women” - Rewording of “EPS including TD across all indications” to

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

If the patient experiences severe rash or hypersensitivity allergic reactions that may appear in the form of rash accompanied by other side effects such as: • fever, • blistering, •

•Increase of drowsiness of H1 antihistamines when co administered with drink alcoholic beverages or taking alchohol •Increased anticholinergic effects of atropine and other atropinic

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

Also, the studies had the doctors of the patients fill out a questionnaire to measure the patients’ change in sleepiness, the so called Clinical Global Impressions scale for change 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

VI.2.2 Summary of treatment benefits Bendamustine is used alone monotherapy or in combination with other medicines for the treatment of the following forms of cancer: – Chronic