Specific conditions of registration applying to these goods The Xtandi EU-RMP, version 7.0 6 October 2014, Data Lock Point 16 September 2013 for Phase III Study MDV3100-03 and 1 July 2013 for the remaining studies in the Integrated Safety Population) and ASA version 1.2 (dated 17 October 2014), and any subsequent revisions, as agreed with the TGA will be implemented in Australia. Attachment 1. Product Information The PI approved for Xtandi at the time this AusPAR was published is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
Specific conditions of registration applying to these goods The Xtandi EU-RMP, version 7.0 6 October 2014, Data Lock Point 16 September 2013 for Phase III Study MDV3100-03 and 1 July 2013 for the remaining studies in the Integrated Safety Population) and ASA version 1.2 (dated 17 October 2014), and any subsequent revisions, as agreed with the TGA will be implemented in Australia. Attachment 1. Product Information The PI approved for Xtandi at the time this AusPAR was published is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
auspar-enzalutamide-160323.docx