Haemodynamically unstable The sponsor has updated the This is acceptable from a RMP standpoint PE patients is a new item of Product Information. subject to final missing information directly consideration by the relating to the proposed Delegate. indications. The approved US product label includes a related precaution. It is recommended that a similar precaution is included in the Australian PI as routine risk minimisation for the missing information Haemodynamically unstable PE patients. This should be appropriately reflected in the EU-RMP and/or ASA. The sponsor has updated the This is acceptable from The EU and US product labels Product Information in line with a RMP standpoint include a precaution the recommendation in the US subject to final regarding temporary product information. consideration by the discontinuation of apixaban Delegate. and the associated increased risk of thrombosis. The corresponding precaution in the Australian PI focuses more on the increased risk of stroke when transitioning from apixaban to warfarin. Consideration should be made for inclusion of similar advice to the EU Summary of Product Characteristics (SmPC) regarding temporary discontinuation in general. The proposed PI contains The sponsor has updated the This is acceptable from advice on switching between Product Information. a RMP standpoint apixaban and subject to final anticoagulants. It is noted that consideration by the the US product label contains Delegate. the following useful statement regarding measuring INR when switching from apixaban to warfarin: Eliquis affects INR, so that INR measurements during coadministration with warfarin may not be useful for determining the appropriate dose of warfarin. It is recommended that a similar statement is included in the Australian PI. Changes made to the PI in The sponsor provides an This is acceptable. response to the evaluation assurance that any changes
Haemodynamically unstable PE patients is a new item of missing information directly relating to the proposed indications. The approved US product label includes a related precaution. It is recommended that a similar precaution is included in the Australian PI as routine risk minimisation for the missing information Haemodynamically unstable PE patients. This should be appropriately reflected in the EU-RMP and/or ASA. The sponsor has updated the Product Information. This is acceptable from a RMP standpoint subject to final consideration by the Delegate. The EU and US product labels include a precaution regarding temporary discontinuation of apixaban and the associated increased risk of thrombosis. The corresponding precaution in the Australian PI focuses more on the increased risk of stroke when transitioning from apixaban to warfarin. Consideration should be made for inclusion of similar advice to the EU Summary of Product Characteristics (SmPC) regarding temporary discontinuation in general. The sponsor has updated the Product Information in line with the recommendation in the US product information. This is acceptable from a RMP standpoint subject to final consideration by the Delegate. The proposed PI contains advice on switching between apixaban and anticoagulants. It is noted that the US product label contains the following useful statement regarding measuring INR when switching from apixaban to warfarin: Eliquis affects INR, so that INR measurements during coadministration with warfarin may not be useful for determining the appropriate dose of warfarin. It is recommended that a similar statement is included in the Australian PI. The sponsor has updated the Product Information. This is acceptable from a RMP standpoint subject to final consideration by the Delegate. Changes made to the PI in response to the evaluation The sponsor provides an assurance that any changes This is acceptable.
auspar-apixaban-151111.docx