More dual labelled medicines transition to sole names

From 2016, the Therapeutic Goods Administration (TGA) began changing the approved ingredient names for a range of medicines in Australia to be consistent with International Nonproprietary Names (INNs).^1,2 To allow patients and health professionals to become familiar with the new names, some medicines were required to be dual labelled; this meant they were labelled with the new name followed by the previous Australian approved name in brackets.

The requirement for dual labelling ended for most medicines in 2023, but it continued until 30 April 2025 for selected medicines considered higher risk (Table 1). These medicines will now transition to sole approved names.

Table 1 Medicines transitioning to sole approved ingredient names in Australia from May 2025

New approved name	Former approved name
dosulepin	dothiepin
hydroxycarbamide	hydroxyurea
tetracaine	amethocaine
trihexyphenidyl	benzhexol

Medicines with labels using only the new ingredient name will start to appear on shelves over time, as existing stock is sold and new stock is distributed. For example, ‘hydroxycarbamide (hydroxyurea)’ will transition to ‘hydroxycarbamide’ sometime after 1 May 2025.

Medicine sponsors have 3 years to update medicine package labels to show only the new ingredient name. They are also required to update product information and consumer medicines information documents as labels are updated.

A small number of medicines will continue to be dual labelled indefinitely (Box 1).

A complete list of medicines that have undergone name changes, including the original and updated ingredient names, is available on the TGA’s website.³

 

References

1. Yik J. Changing Australian medicine names. Aust Prescr 2017;40:98-100.
2. Therapeutic Goods Administration. Dual labelled medicine ingredient names transition to sole names. Department of Health and Aged Care; 2025. [cited 2025 May 13]
3. Therapeutic Goods Administration. Updating medicine ingredient names - list of affected ingredients. Department of Health and Aged Care; 2023. [cited 2025 May 13]