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OXYCODONE NALOXONE MAPLE (Maple Healthcare Pty Ltd)
Product name
OXYCODONE NALOXONE MAPLE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
142 (255 working days)
Active ingredients
naloxone hydrochloride dihydrate, oxycodone hydrochloride
Registration type
New generic medicine
Indication
[TRADENAME] modified release tablet is indicated for the management of severe pain where:
- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and
- the pain is opioid-responsive; and
- requires daily, continuous, long term treatment.
[TRADENAME] modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.
[TRADENAME] modified release tablet 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.
[TRADENAME] is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.