LODAT SR (Seed Pharma Pty Ltd)
Product name
LODAT SR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
101 (120 working days)
Active ingredients
tapentadol tartrate
Registration type
New generic medicine
Indication
TRADE NAME 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.
TRADE NAME is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.
TRADE NAME is not indicated as an as-needed (PRN) analgesia.