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OXONAL (AU Pharma Pty Ltd)
Product name
OXONAL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
124 (255 working days)
Active ingredients
naloxone hydrochloride dihydrate, oxycodone hydrochloride
Registration type
New generic medicine
Indication
Oxonal modified release tablets are indicated for the management of severe pain where:
- Other treatment options have failed, are contraindicated, not tolerated or areotherwise inappropriate to provide sufficient management of pain, and
- the pain is opioid-responsive; and
- requires daily, continuous, long term treatment.
Oxonal is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.
Oxonal is not indicated as an as-needed (PRN) analgesia.
The naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.
Oxonal is not indicated for the treatment of patients with restless legs syndrome.