BUPRENO; B-PATCH; BUPE-PATCH; BUPRENORPHINE AUP (Juno Pharmaceuticals Pty Ltd)
Product name
BUPRENO; B-PATCH; BUPE-PATCH; BUPRENORPHINE AUP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
145 (255 working days)
Active ingredients
buprenorphine
Registration type
New generic medicine
Indication
Buprenorphine patches (transdermal drug delivery system) are 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.
Buprenorphine patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances.
Buprenorphine patches are not indicated as an as-needed (PRN) analgesia.