Product is POM only

Risk minimisation measures Routine risk communication: None Routine risk minimisation activities recommending specific clinical measures to address the risk: None Other routine

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 minimisation measures Routine Risk minimization measures: SmPC sections 4.2, 4.3, 4.4, 4.8 and 5.2 Other routine risk minimisation measures: Prescription only medicine

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

13.3 Part VI.2.5 Summary of additional risk minimization measures by safety concern These additional risk minimization measures are for the following risks:  High blood pressure

Additional risk minimisation measures are for the following risk: Abacavir Hypersensitivity Reactions Risk minimisation measures: • An alert card for Abacavir Hypersensitivity

Deferasirox Film-coated tablets Risk Management Plan Jubilant Pharmaceuticals NV Risk minimisation measures Routine risk minimization measures: SmPC Section 4.2 Posology and method

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