LUCASSIN (Ikaria Australia Pty Ltd)

Product name

LUCASSIN

Date registered

7 June 2018

Evaluation commenced

29 June 2017

Decision date

29 May 2018

Approval time

201 working days (255)

Active ingredients

terlipressin

Registration type

EOI

Indication

LUCASSIN (injection) is now also indicated for the treatment of bleeding oesophageal varices.

Registration process

Orphan drug

Sponsors receive a fee waiver to help bring medicines for a small population to market.