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National Drug Formulary

IQIRVO® FILM-COATED TABLET 80MG [SIN17332P]

Active ingredients: IQIRVO® FILM-COATED TABLET 80MG

View product's general information
Last updated 24 April 2026

Product Info

IQIRVO® FILM-COATED TABLET 80MG

[SIN17332P]

Product information

Active Ingredient and Strength

ELAFIBRANOR - 80 MG

Dosage Form

TABLET, FILM COATED

Manufacturer and Country

DELPHARM MILANO S.R.L. - ITALY

Registration Number

SIN17332P

Licence Holder

IPSEN PHARMA SINGAPORE PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

A05AX06

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1 Therapeutic indications

IQIRVO® is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adult patients with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

Dosing

4.2 Posology and method of administration

Posology

The recommended dose is 80 mg once daily with or without food.

Special Populations

Elderly patients (65 years of age and above)
No dose adjustment is necessary in patients older than 65 years of age (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dose adjustment is necessary in patients with renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is necessary in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
The safety and efficacy of elafibranor have not been established in patients with PBC with severe hepatic impairment. Use in patients with severe hepatic impairment (Child-Pugh C) is not recommended (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
There is no relevant use of elafibranor in the paediatric population (below 18 years of age) for the indication of PBC.

Missed dose
If a dose of elafibranor is missed, the patient should not take the missed dose and instead take their subsequent dose at the next scheduled time point. The patient should not take a double dose to make up for the missed dose.

Method of administration

For oral use.
Take one tablet once daily.

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.