Glycophos
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 January 2019 |
| First round evaluation completed | 20 June 2019 |
| Sponsor provides responses on questions raised in first round evaluation | 16 July 2019 |
| Second round evaluation completed | 31 July 2019 |
| Delegate's overall benefit-risk assessment | 20 October 2019 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 13 November 2019 |
| Completion of administrative activities and registration on ARTG | 14 November 2019 |
| Number of working days from submission dossier acceptance to registration decision* | 199 |
*Statutory timeframe for standard applications is 255 working days
Adults
The recommended dosage should be individualised to each patient's phosphorus status and needs. Approximately 15 mmol of phosphate is provided by a litre of lipid emulsions or amino acid solutions. This should be considered when supplementing phosphate from Glycophos. The normal requirements during parenteral nutrition can be met by using 10 to 20 mL of Glycophos added to the infusion solution or admixture for which compatibility has been proven.
Paediatric population
The recommended dosage should be individualised to each patient's phosphorous status and needs. The recommended dose for children, infants and neonates is 1.0 to 1.5 mmol/kg body weight per day.
For further information refer to the Product Information.
Glycophos (sodium glycerophosphate (as hydrate)) was approved for the following therapeutic use:
Glycophos is indicated in adult and paediatric patients as a supplement to parenteral nutrition to meet the daily requirements of phosphate.
For all injectable products the Product Information must be included with the product as a package insert.