Pack size changes – Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension

From 1 July 2025, the pack sizes of Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension have changed to reflect the final volumes of the suspension after reconstitution.

The pack size licensed for children weighing 4 kg and more is now expressed as a quantity of 103.4ml (previously 100ml bottle size).

The pack size licensed for children weighing less than 4 kg is now expressed as a quantity of 51.7ml (previously 50ml bottle size).

Previously, the pack sizes listed in the Drug Tariff and the NHS dictionary of medicines and devices (dm+d) represented the volumes of water added for reconstitution and not the final reconstituted volumes of the suspension after reconstitution – see table below.

Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension

Previous listing (based on volumes of water added for reconstitution) New pack size listing effective 1 July 2025 Listed in Part VIII of the Drug Tariff 

50ml 

Licensed for children weighing less than 4kg

51.7ml

 

No

 

100ml

Licensed for children weighing 4kg or more 

103.4ml

 

Yes

 

These pack size changes follow identification by Community Pharmacy England of previous discrepancies between the described and actual reconstituted volumes for Xarelto® (Rivaroxaban) 1mg/ml granules for oral suspension.

Please note pharmacies may continue to receive prescriptions for the older pack sizes until all prescribing systems have been updated to reflect these change. As both pack sizes are special containers, the nearest complete pack size to the quantity ordered should continue to be supplied.

 

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