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IQIRVO (Ipsen Pty Ltd)
Product name
IQIRVO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
219 (255 working days)
Active ingredients
elafibranor
Registration type
NCE/ NBE
Indication
IQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.