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Recognising the needs of a small group of patients who would be left without adequate pain relief if DiGesic and Doloxene were no longer available, the Administrative Appeals Tribunal (AAT) has declined to uphold a decision of the Minister/TGA to cancel the registrations of DiGesic and Doloxene.

The Tribunal accepts that DiGesic [and Doloxene] are efficacious.  Concerns remain about the risk of deliberate and accidental overdose however, the Tribunal recognises that there is a small group of patients for whom alternative pain relief products may not be effective and tolerable.

The Tribunal also notes that the literature indicates that the safety of DPP at therapeutic doses is not materially different to other weak opioids and does not support a finding under the Therapeutic Goods Act that the safety of DPP is unacceptable.

The decision has been remitted to the Minister/TGA to consider appropriate conditions on the registration of DiGesic and Doloxene.  In the interim, both products will remain on the ARTG.

Below is the full determination from the AAT for your information.

Content Last Reviewed On July 16, 2018

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