In 2016, the Therapeutic Goods Administration (TGA) began to change approved medicine ingredient names 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 labelled with the new name followed by the previous Australian approved name in brackets until at least 30 April 2023. For example, products containing furosemide had to be dual labelled as ‘furosemide (frusemide)’.2

The requirement for dual labelling for most medicines has now ended. However, following consultations with health professionals and other relevant stakeholders, it was determined that dual labelling should be continued for a small number of medicines until 30 April 2025 or indefinitely (Box 1).

Box 1 - Medicines requiring dual-ingredient labelling [NB1]

Medicines that require dual-ingredient labelling until 30 April 2025:

  • dosulepin (dothiepin)
  • hydroxycarbamide (hydroxyurea)
  • tetracaine (amethocaine)
  • trihexyphenidyl (benzhexol).

Medicines with no planned transition to sole-ingredient labelling:

  • alimemazine (trimeprazine)
  • mercaptamine (cysteamine)
  • Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain).

Medicines that require dual-ingredient labelling permanently:

  • adrenaline (epinephrine)
  • noradrenaline (norepinephrine).

NB1: Dual-ingredient labelling consists of the International Nonproprietary Name (INN) followed by the previous Australian approved name in brackets. The exception is adrenaline and noradrenaline, which have their Australian approved name listed first followed by the INN in brackets.

Medicines that are changing from dual- to sole-ingredient labelling can be found on the TGA’s list of affected ingredient names.3 Medicine sponsors have 3 years to update medicine package labels to show only the new ingredient name. Changes will appear gradually, as existing stock is sold and new stock is distributed. Medicine sponsors are also required to update product information and consumer medicines information documents as labels are updated.

On 1 August 2023, the Pharmaceutical Benefits Scheme Schedule was updated to reflect changes to dual-labelling requirements.


Australian Prescriber welcomes Feedback.

Creative Commons License