Information updates

EpiPen® supply update

2 January 2020

Mylan, the supplier of 150 mcg EpiPen® Jr and 300 mcg EpiPen® adrenaline (epinephrine) autoinjectors in Australia and New Zealand, recently advised the Therapeutic Goods Administration (TGA) of the outcomes of testing of EpiPen® products. Meridian Medical Technologies, the manufacturer of EpiPen® products, has undertaken a thorough investigation into the presence of very low levels of another medicine, pralidoxime, in EpiPen® Jr products. This included testing of batches of both the 150 mcg and 300 mcg versions of the product. The investigation has identified that a batch of 300 mcg EpiPen® (batch number 9KB643), which is available in Australia, also contains trace levels of pralidoxime. However, the trace levels in this batch are in the nanogram range (one billionth of a gram), and these levels are considered to be negligible.

The TGA has reviewed the outcomes of the investigation and is satisfied that these products meet the required standards for safety. The manufacturing issue has now been fully corrected and production has resumed.

EpiPen® products are critical, life-saving medicines. The TGA is committed to facilitating the ongoing availability of these medicines for Australians and continues to work closely with Mylan to ensure supply.

For information about EpiPen® Jr supply go to:

www.tga.gov.au/alert/epipen-jr

www.allergy.org.au/about-ascia/info-updates/further-important-about-epipen-jr-supply

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