the EU SmPC is more The EU RMP version 11 and the restrictive. ASA guidance can amended ASA were provided. be found on the TGA website. Summary of recommendations It is considered that the sponsor’s response to the TGA’s request for further information has adequately addressed the issues identified in the RMP evaluation report Additional recommendations are summarised Outstanding issues Issues in relation to the RMP The clinical evaluator has recommended that in the elderly’ be as an item of ‘Use missing information to the RMP and/or the ASA. The sponsor should add this item of missing information to the RMP and/or the ASA prior to finalisation unless a compelling justification can be provided for its omission. It is considered that routine risk minimisation and pharmacovigilance would be acceptable for this additional item of missing information. The evaluator has no objection to the educational materials. Once finalised, these should be provided to the TGA. Advice from the Advisory Committee on the Safety of Medicines (ACSOM) ACSOM advice was not sought for this submission. Key changes to the updated RMP EU-RMP version 10.0 (dated 9 May 2014, DLP 16 December 2013) and Australian Specific Annex version 4.0 (dated 28 January 2015) has been superseded by EU-RMP version 11.0 (dated 29 April 2015, DLP 27 February 2015) and Australian Specific Annex version 5.0 (dated 8 September 2015) and the key changes are summarised below in Table 8. 8: Summary of key changes to the EU-RMP Summary of key changes noted between EU RMP v10/ASA v4 and EU RMP v11/ASA v5 Safety New potential mediated reactions’, Lesions’, ‘Immune ‘Skin specification of the Urethra’, label use in patients with ventral ‘Injury ‘Off curvature deformity’, label use in patients with isolated ‘Off hourglass deformity’. Pharmacovigilance plan for new potential risks added (NB these activities safety concerns appear to have been incorporated into existing pharmacovigilance activities a targeted questionnaire is also – proposed for mediated reactions’). ‘Immune Risk Risk minimisation activities are now proposed for the new minimisation potential risks activities A non-interventional post-authorisation safety study is now proposed to evaluate the effectiveness of the implemented additional risk minimisation measures in the EU.
the EU SmPC is more restrictive. ASA guidance can be found on the TGA website. The EU RMP version 11 and the amended ASA were provided. Summary of recommendations It is considered that the sponsor’s response to the TGA’s request for further information has adequately addressed the issues identified in the RMP evaluation report Additional recommendations are summarised Outstanding issues Issues in relation to the RMP The clinical evaluator has recommended that ‘Use in the elderly’ be as an item of missing information to the RMP and/or the ASA. The sponsor should add this item of missing information to the RMP and/or the ASA prior to finalisation unless a compelling justification can be provided for its omission. It is considered that routine risk minimisation and pharmacovigilance would be acceptable for this additional item of missing information. The evaluator has no objection to the educational materials. Once finalised, these should be provided to the TGA. Advice from the Advisory Committee on the Safety of Medicines (ACSOM) ACSOM advice was not sought for this submission. Key changes to the updated RMP EU-RMP version 10.0 (dated 9 May 2014, DLP 16 December 2013) and Australian Specific Annex version 4.0 (dated 28 January 2015) has been superseded by EU-RMP version 11.0 (dated 29 April 2015, DLP 27 February 2015) and Australian Specific Annex version 5.0 (dated 8 September 2015) and the key changes are summarised below in Table 8. 8: Summary of key changes to the EU-RMP Summary of key changes noted between EU RMP v10/ASA v4 and EU RMP v11/ASA v5 Safety specification New potential ‘Immune mediated reactions’, ‘Skin Lesions’, ‘Injury of the Urethra’, ‘Off label use in patients with ventral curvature deformity’, ‘Off label use in patients with isolated hourglass deformity’. activities Pharmacovigilance plan for new potential risks added (NB these safety concerns appear to have been incorporated into existing pharmacovigilance activities – a targeted questionnaire is also proposed for ‘Immune mediated reactions’). Risk minimisation activities Risk minimisation activities are now proposed for the new potential risks A non-interventional post-authorisation safety study is now proposed to evaluate the effectiveness of the implemented additional risk minimisation measures in the EU.
auspar-collagenase-clostridium-histolyticum-160802.docx