Information on the number of doses to be released in Australia with accompanying expiry dates for the product and diluents (if included). Evidence of the maintenance of registered storage conditions during transport to Australia. Five vials of each batch for testing by the TGA Laboratories Branch together with any necessary standards, impurities and active pharmaceutical ingredients (with their Certificates of Analysis) required for method development and validation. Attachment 1. Product Information The PI for Tecentriq approved with the submission is described in this AusPAR is at Attachment 1. For the most recent PI, please refer to the TGA website at <>. Attachment 2. Extract from the Clinical Evaluation Report
Information on the number of doses to be released in Australia with accompanying expiry dates for the product and diluents (if included). Evidence of the maintenance of registered storage conditions during transport to Australia. Five vials of each batch for testing by the TGA Laboratories Branch together with any necessary standards, impurities and active pharmaceutical ingredients (with their Certificates of Analysis) required for method development and validation. Attachment 1. Product Information The PI for Tecentriq approved with the submission is described in this AusPAR 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-atezolizumab-180903.docx