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REVESTIVE (Shire Australia Pty Ltd)
Product name
REVESTIVE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
203 working days (255)
Active ingredients
teduglutide
Registration type
EOI
Indication
REVESTIVE (powder for solution for injection) is now also indicated for the treatment of paediatric patients 2 year of age and above with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.