ESOMEPRAZOLE IV MYLAN (Alphapharm Pty Ltd)
Product name
ESOMEPRAZOLE IV MYLAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
210 (255 working days)
Active ingredients
esomeprazole sodium
Registration type
New generic medicine
Indication
ESOMEPRAZOLE IV MYLAN (powder for injection) is indicated for the short-term management of Gastro-Oesophageal Reflux Disease (GORD) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate.
Prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers.
Short-term management in patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy when oral therapy is inappropriate:
- healing of gastric ulcers associated with NSAID therapy
- prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk
ESOMEPRAZOLE IV MYLAN should be replaced with oral therapy as soon as practicable.