The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||28 September 2018|
|First round evaluation completed||29 April 2019|
|Sponsor provides responses on questions raised in first round evaluation||3 May 2019|
|Second round evaluation completed||31 May 2019|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||1 July 2019|
|Sponsor's pre-Advisory Committee response||N/A|
|Advisory Committee meeting||N/A|
|Registration decision (Outcome)||9 July 2019|
|Completion of administrative activities and registration on ARTG||6 September 2019|
|Number of working days from submission dossier acceptance to registration decision*||153|
*Statutory timeframe for standard applications is 255 working days
The recommended dosage of Ziextenzo is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle, approximately 24 hours after the administration of cytotoxic chemotherapy.
For further information refer to the Product Information.
Ziextenzo (pegfilgrastim) was approved for the following therapeutic use:
Ziextenzo is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.
For all injectable products the Product Information must be included with the product.