Change is coming

antibiotics pills medicines

Get ready for the big ingredient name changes in 2020, regulator warns

The TGA is advising health professionals and consumers alike to be ready for the 2020 deadline for the alteration to the naming of hundreds of medicine ingredients.

From the 1 May 2020 all medicines released for supply in Australia must use the new ingredient names. A total of 227 ingredients will have their name altered in some from this date.

In its latest advice, posted this week, the TGA says “the four year transition period has provided sufficient time for sponsors to move over to using the new names.

With less than 12 months left, consumers and health professionals are expecting to see the new ingredient names on medicine labels and relevant documentation”.

Some products will have dual labelling, including both the old and new name as displayed below on the product label until 2023, others have significant changes, or minor spelling changes, or simply have the hydration changed in the name  (an example of the latter is Calcium gluconate changing to Calcium gluconate monohydrate).

Examples of ingredients whose names are changing are:

  • Oestradiol to estradiol
  • Phytic Acid to fytic acid 
  • Dexamphetamine sulfate to dexamfetamine sulfate
  • Cephalexin to cefalexin monohydrate
  • Amoxycillin to amoxicillin
  • thyroxine sodium to levothyroxine sodium
  • Diclofenac diethylammonium to diclofenac diethylamine
  • Chitosan to poliglusam
  • Hexamine hippurate to methenamine hippurate
  • Manganese aspartate to manganese diaspartate

The pharmaceutical industry is being advised that: “sponsors need to make sure that all relevant documentation is being updated and to minimise stock that still use old ingredient names. This will help to reduce confusion for consumers as we approach the end of the transition period.

Generic sponsors can update ingredient names in their medicines documentation without waiting for the innovator to change their products”.

Click here to see the full list of affected ingredients.


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