Iqirvo
What Iqirvo is used for
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 patients unable to tolerate UDCA.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Iqirvo
- Active substance
- elafibranor
- Disease area
- Liver Cirrhosis, Biliary
- Medicine group
- Bile and liver therapy
- ATC code
- A05AX06
- Marketing authorisation holder
- Ipsen Pharma
- Authorised in the EU since
- 2024
Official information
In the USA
Same active substance: Iqirvo
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Iqirvo used for?
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 patients unable to tolerate UDCA.
What is the active substance in Iqirvo?
Iqirvo contains elafibranor.
Who makes Iqirvo?
The EU marketing authorisation holder is Ipsen Pharma.
Is Iqirvo an orphan medicine?
Yes. Iqirvo is designated an orphan medicine in the EU, for a rare disease (Liver Cirrhosis, Biliary).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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