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Glycophos
Sponsor
Device/Product name
Glycophos
Active Ingredient
Sodium glycerophosphate (as hydrate)
Date of decision
Published
Submission type
New chemical entity
ATC codes
B05XA14
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing) and clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Glycophos was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
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
Date of entry onto ARTG
Original publication date
Black triangle scheme
No
Dose forms
Concentrated solution for injection
Strength
4.32 g/20 mL
Other ingredients
Hydrochloric acid (pH adjuster), Water for injections
Containers
Ampoule
Pack sizes
20
Routes of administration
Intravenous infusion
Dosage
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.
Pregnancy category
This therapeutic good is exempted from pregnancy categorisation.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
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.
What is this medicine and how does it work
Sodium glycerophosphate is an organic phosphate salt.Glycerophosphate is a metabolic intermediate in fat metabolism. It is used as a supplement to parenteral nutrition to meet the daily requirements of phosphate.
What post-market commitments will the sponsor undertake
For all injectable products the Product Information must be included with the product as a package insert.