Part VI: Summary of the risk management plan by product

Tiotropium RMP v 2.1 TEVA CONFIDENTIAL Page 40 of 50 II.B Summary of Important Risks Table 10: Summary of Risk Minimisation Activities by Safety Concern Important potential risk:

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

EU-Risk Management Plan for Tadalafil NL/H/3649/001-003 V1.0 STADA Arzneimittel AG C O N F I D E N T I A L Page 13 of 73 Part VI Summary of the risk management plan VI.1

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

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

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

Risk Management Plan Page 12/15 II.A List of important risks and missing information Important risks of Icatibant STADA 30 mg/3 ml injektionsvæske, opløsning are risks that need

Risk Management Plan Oxybate Reig Jofre 500 mg/ml oral solution Important identified risk: CNS Depression Risk minimisation measures Routine risk minimisation measures This risk