PDF PART VI - Summary of the risk management plan

List of important risks and missing information Important Identified Risks • Hyperkalemia Important Potential Risks • Venous Thromboembolism • Bone fracture/Decrease in bone

Moxifloxacin RMP v2.1 TEVA CONFIDENTIAL Page 15 of 25 II.A List of Important Risks and Missing Information Important risks of Moxifloxacin are risks that need special risk

Risk Management Plan Page 12/13 II.A List of important risks and missing information Important risks of Icatibant AdAlvo 30 mg/3 ml injektionsvæske, opløsning are risks that need

Summary of safety concerns Important identified risks Second primary malignancies Serious infection due to neutropenia Teratogenicity Important potential risks Cardiac arrhythmias

Caspofungin RMP v 2.2 TEVA CONFIDENTIAL Page 15 of 25 II.A List of Important Risks and Missing Information Important risks of Caspofungin are risks that need special risk management

List of important risks and missing information Important identified risks  Injection site reactions Important potential risks  Deterioration of cardiac function under ischaemic

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

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