CIPLA TEDUGLUTIDE (Cipla Australia Pty Ltd)
Product name
CIPLA TEDUGLUTIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
Active ingredients
teduglutide
Registration type
NCE/NBE
Indication
TRADE NAME is indicated for the treatment of adult and paediatric patients 2 years of age and above with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Patients should be stable for at least 4 weeks on their parenteral support regimen before initiating teduglutide therapy.