has been superseded by: EU Risk Management Plan Version 2.5 (dated 12 August 2014, DLP 28 February 2013) and Australian Specific Annex Version 2.1 (dated September 2014). Key changes to the EU-RMP and ASA are highlighted in Table 8 below. Table 8: Summary of key changes to the RMP and ASA Key changes between EU-RMP Version 2.0 and EU-RMP Version 2.5 Safety microangiopathies’ (TMA) added as Important ‘Thrombotic specification Potential Risk. safety in GIST patients’ added as Missing ‘Long-term Information. in severe or moderate hepatic impairment’ added as ‘Safety Missing Information (previously in severe hepatic ‘Safety impairment’). in severe or moderate impairment’ added as ‘Safety Missing Information (previously in severe renal ‘Safety impairment’). Study 14814 (Category 3) completed; Result summary added activities to section 3 in Part III; Clinical Study Report added to Annex 9. Study 14874 assigned to safety in GIST patients’ ‘Long-term Updates on due dates for study 15808 and 15967. ASA ASA updated to accommodate EU-RMP changes. Suggested wording for conditions of registration RMP Any changes to which the sponsor agreed become part of the risk management system, whether they are included in the currently available version of the RMP document, or not included, inadvertently or otherwise. The suggested wording is: Implement EU Risk Management Plan Version 2.5 (dated 12 August 2014, DLP 28 February 2013) and Australian Specific Annex Version 2.1 (dated September 2014), and future updates, where approved by the TGA, as a condition of registration VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations: Quality There was no requirement for a quality evaluation in a submission of this type.
has been superseded by: EU Risk Management Plan Version 2.5 (dated 12 August 2014, DLP 28 February 2013) and Australian Specific Annex Version 2.1 (dated September 2014). Key changes to the EU-RMP and ASA are highlighted in Table 8 below. Table 8: Summary of key changes to the RMP and ASA Key changes between EU-RMP Version 2.0 and EU-RMP Version 2.5 Safety specification ‘Thrombotic microangiopathies’ (TMA) added as Important Potential Risk. ‘Long-term safety in GIST patients’ added as Missing Information. ‘Safety in severe or moderate hepatic impairment’ added as Missing Information (previously ‘Safety in severe hepatic impairment’). ‘Safety in severe or moderate impairment’ added as Missing Information (previously ‘Safety in severe renal impairment’). activities Study 14814 (Category 3) completed; Result summary added to section 3 in Part III; Clinical Study Report added to Annex 9. Study 14874 assigned to ‘Long-term safety in GIST patients’ Updates on due dates for study 15808 and 15967. ASA ASA updated to accommodate EU-RMP changes. Suggested wording for conditions of registration RMP Any changes to which the sponsor agreed become part of the risk management system, whether they are included in the currently available version of the RMP document, or not included, inadvertently or otherwise. The suggested wording is: Implement EU Risk Management Plan Version 2.5 (dated 12 August 2014, DLP 28 February 2013) and Australian Specific Annex Version 2.1 (dated September 2014), and future updates, where approved by the TGA, as a condition of registration VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations: Quality There was no requirement for a quality evaluation in a submission of this type.
auspar-regorafenib-151119.docx