Australia: Transitions to Sole Ingredient Names on Medicine Labels (w.e.f 1 May 2025)

Starting 1 May 2025, medicine labels in Australia will begin to phase out dual ingredient names and move towards using only the updated international ingredient names. This marks the next phase in a long-running effort to align Australian medicine naming conventions with international standards, enhancing consistency and safety for both consumers and healthcare professionals.

What is Dual Labelling?

Since May 202, some medicines in Australia have been labelled using both old and the new international name for active ingredients – a process known as dual labelling.

For example: hydroxycarbamide (hydroxyurea) or lidocaine (lignocaine)

This initiative was introduced to give healthcare professionals and patients sufficient time to become familiar with changes in ingredient names and eventually to use just one internationally recognized name for each ingredient.

Transition Timeline

Ingredients Affected by the Extended Transition Ending 30 April 2025

The following ingredient names will begin transitioning to sole names starting 1 May 2025:

• Dosulepin (dothiepin) hydrochloride

• Hydroxycarbamide (hydroxyurea)

• Tetracaine (amethocaine)

• Tetracaine (amethocaine) hydrochloride

• Trihexyphenidyl (benzhexol) hydrochloride

  
  

By 1 May 2028, medicine labels for these ingredients must show only the new name.

Ongoing Dual Labelling for Select Ingredients

A small set of ingredient names will continue with dual labelling indefinitely, including:

• Alimemazine (trimeprazine) tartrate

• Mercaptamine (cysteamine) and its derivatives

• Mycobacterium bovis (Bacillus Calmette and Guerin [BCG] strain)

  
  

These ingredients are listed in the Australian Approved Names List and are not currently scheduled to more to sole naming.

As label begins to reflect only the new names, health professionals must verify ingredients carefully during prescribing, dispensing, and administering medications. Besides, it is important to refer to the updated Product Information (PI) and Consumer Medicine Information (CMI) documents, and educate patients who may be unfamiliar with the new ingredient names.

This change is part of the International Harmonisation of Ingredient Names (IHIN) initiative, which aims to align Australia’s medicine labels with those used globally. This helps reduce confusion and supports safer medication practices, especially for travellers, healthcare professionals working internationally, and those accessing global medical literature.

Stay informed to get the latest updates and understand how these changes may impact you or your practice. Further inquiries may be directed to info@arqon.com.

Source: Therapeutic Goods Administration (TGA)