Part VI: Summary of the risk management plan by product

• Long-term risk of malignant neoplasms • Unexplained death • Switch from other disease modifying therapy II.B Summary of important risks Important identified risks

Prophylactic treatment with anti-androgens Changes to the liver and jaundice yellow eyes and skin Occurrence of hepatic dysfunction and jaundice with elevated liver enzyme levels the

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

Not applicable Not applicable Not applicable Not applicable Table 1-4 Summary table of Risk Minimization Measures Safety concern Routine risk minimization measures Additional

on the long-term use of the medicine; Summary of safety concerns Important identified risks • Agranulocytosis • Neutropenia • Use in pregnancy Important potential risks None

on the long‐ term use of the medicine; Summary of safety concerns Important identified risks - Risk of accumulation in patients with kidney or liver failure Important potential

on the long-term use of the medicine; Summary of safety concerns Important identified risks • Nasal septum perforation • Growth retardation in children receiving prolonged treatment

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