HYDROMORPHONE-HAMELN; HYDROMORPHONE-HAMELN-HP (Hameln Pharma Pty Ltd)
Product name
HYDROMORPHONE-HAMELN; HYDROMORPHONE-HAMELN-HP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
135 (255 working days)
Active ingredients
hydromorphone hydrochloride
Registration type
New generic medicine
Indication
HYDROMORPHONE-HAMELN; HYDROMORPHONE-HAMELN-HP (solution for injection) is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.