The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced
|2 December 2019
|First round evaluation completed
|30 April 2020
|Sponsor provides responses on questions raised in first round evaluation
|26 June 2020
|Second round evaluation completed
|5 August 2020
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice
|9 September 2020
|Sponsor's pre-Advisory Committee response
|Advisory Committee meeting
|Registration decision (Outcome)
|14 October 2020
|Completion of administrative activities and registration on ARTG
|15 October 2020
|Number of working days from submission dossier acceptance to registration decision*
*Statutory timeframe for standard applications is 255 working days
Insulin aspart has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, insulin aspart should generally be given immediately before a meal or when necessary, soon after the start of a meal.
The dosage of insulin aspart is determined by the physician according to the patient's individual needs. The individual insulin requirement is usually between 0.5 and 1.0 units/kg/day in adults and children. In a meal related treatment 50 to 70% of this requirement may be provided by Truvelog and the remainder provided by an intermediate-acting or long-acting insulin given at least once a day.
For further information refer to the Product Information.
Truvelog (insulin aspart) was approved for the following therapeutic use:
Treatment of diabetes mellitus.
- This approval does not impose any requirement for the submission of Periodic Safety Update reports. It should be noted that it is a requirement that all existing requirements for the submission of PSURs as a consequence of the initial registration or subsequent changes must be completed.
- The Consumer Medicines Information (CMI) and Instructions for Use (IFU) leaflet must be included with the products as package insert. The CMI should have a link to the full version of the Product Information (PI) on the TGA website.
- Laboratory testing and compliance with Certified Product Details (CPD)
- All batches of Truvelog supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the CPD.
- When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Products. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.