XERMELO (Ipsen Pty Ltd)
Product name
XERMELO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
219 working days (255)
Active ingredients
telotristat etiprate
Registration type
NCE/NBE
Indication
XERMELO (film coated tablets) is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.