Table 16: Key changes between EU-RMP versions 5.0 and 6.0 Summary of key changes between EU RMP Version 5.0 and EU RMP Version 6.0 Safety specification and have been added as Important Identified ‘Overdose’ ‘Medication Risks dependence and drug withdrawal syndrome’ has been changed to ‘Physical dependence and drug withdrawal syndrome’ as an Important ‘Drug Identified Risk overdose’ has been removed as an Important Potential Risk ‘Accidental dependence’ has been removed as an Important Potential ‘Psychological Risk hepatic events’ has been changed to Disorders’ as an ‘Serious ‘Hepatic Important Potential Risk attack/reaction’ has been added as an Important Potential Risk has been as an Important Potential Risk ‘Aphasia’ Use’ as Missing Information has been changed to in ‘Paediatric ‘Use paediatric patients < 18 in patients with hepatic impairment’ and in patients with renal ‘Use ‘Use impairment’ have been added as Missing Information use in RLS’ has been changed to use’ as Missing ‘Off-label ‘Off-label Information Pharmacovigilance Epidemiological OXN9514 has been added as additional activities Pharmacovigilance for the safety concerns of dependence and drug ‘Drug withdrawal syndrome’ and abuse, misuse and diversion’ ‘Drug Risk minimisation Only routine risk minimisation is now proposed for all safety concerns activities (reference to educational materials has been removed in EU RMP Version 6.0). ASA The ASA has not been updated to reflect the Safety Specification in Version 6.0 of the EU RMP; it reflects the safety concerns of EU RMP Version 5.0, but with removal of the educational materials as additional risk minimisation. The ASA (as Version 6.0) should be updated to reflect the safety concerns identified in Version 6.0 of the EU RMP. Suggested wording for conditions of registration RMP The RMP wording for conditions of registration cannot be provided at this time. Suggested wording cannot be provided until the outstanding RMP issues detailed in this report are satisfactorily addressed. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations:
Table 16: Key changes between EU-RMP versions 5.0 and 6.0 Summary of key changes between EU RMP Version 5.0 and EU RMP Version 6.0 Safety specification ‘Overdose’ and ‘Medication have been added as Important Identified Risks ‘Physical dependence and drug withdrawal syndrome’ has been changed to ‘Drug dependence and drug withdrawal syndrome’ as an Important Identified Risk ‘Accidental overdose’ has been removed as an Important Potential Risk ‘Psychological dependence’ has been removed as an Important Potential Risk ‘Serious hepatic events’ has been changed to ‘Hepatic Disorders’ as an Important Potential Risk attack/reaction’ has been added as an Important Potential Risk ‘Aphasia’ has been as an Important Potential Risk ‘Paediatric Use’ as Missing Information has been changed to ‘Use in paediatric patients < 18 ‘Use in patients with hepatic impairment’ and ‘Use in patients with renal impairment’ have been added as Missing Information ‘Off-label use in RLS’ has been changed to ‘Off-label use’ as Missing Information Pharmacovigilance activities Epidemiological OXN9514 has been added as additional Pharmacovigilance for the safety concerns of ‘Drug dependence and drug withdrawal syndrome’ and ‘Drug abuse, misuse and diversion’ Risk minimisation activities Only routine risk minimisation is now proposed for all safety concerns (reference to educational materials has been removed in EU RMP Version 6.0). ASA The ASA has not been updated to reflect the Safety Specification in Version 6.0 of the EU RMP; it reflects the safety concerns of EU RMP Version 5.0, but with removal of the educational materials as additional risk minimisation. The ASA (as Version 6.0) should be updated to reflect the safety concerns identified in Version 6.0 of the EU RMP. Suggested wording for conditions of registration RMP The RMP wording for conditions of registration cannot be provided at this time. Suggested wording cannot be provided until the outstanding RMP issues detailed in this report are satisfactorily addressed. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations:
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