PART VI Summary of activities in 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:

Risks associated with the medicine and activities to minimise or further characterise the risks Important risks of Rocuronium-hameln 10 mg/ml solution for injection / infusion,

Risk minimisation measures Routine risk minimisation measures SmPC sections 4.4 and 4.8 PL section 2 and 4 Legal status: prescription only medicine Additional risk minimisation

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

Risk factors and risk groups Patients with a history of hypersensitivity to macrolide antibiotics Risk minimisation measures Routine risk minimisation measures SmPC sections 4.4 and

- Yes, for the use of Cefuroxime 750 mg and 1500 mg special advise is given in section 4.8 of the applicants SmPC as following: The most common adverse reactions are neutropenia,

Page 58 of 71 Safety concern Risk minimisation measures Pharmacovigilance activities Important potential risks: Increased risk of hip, wrist and spine fracture Routine risk

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