B-PATCH (AU Pharma Pty Ltd)
Product name
B-PATCH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
171 (255 working days)
Active ingredients
Buprenorphine
Registration type
New generic medicine
Indication
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.
Not indicated for use in chronic non-cancer pain other than in exceptional circumstances.
Not indicated as an as-needed (PRN) analgesia.