NALOXONE RMB, NALOXONE SXP, NALOXONE TLB (Southern Cross Pharma Pty Ltd)
Product name
NALOXONE RMB, NALOXONE SXP, NALOXONE TLB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
114 working days (255)
Active ingredients
naloxone hydrochloride dihydrate
Registration type
New generic medicine
Indication
NALOXONE RMB, NALOXONE SXP, NALOXONE TLB (solution for injection) is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, codeine, morphine and heroin, and the mixed opioid agonist-antagonist analgesics such as pentazocine. Naloxone is also indicated for the diagnosis of suspected acute opioid overdosage.