United States

Cholestatic pruritus in ALGS patients three months and older

Prescribing Information and Important Safety Information

European Union

Cholestatic pruritus in ALGS patients two months and older

SMPC

Canada

Cholestatic pruritus in ALGS patients

• Pediatrics (12 months to 18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of LIVMARLI in these pediatric patients have been established. Therefore, Health Canada has authorized an indication for pediatric use.
• Pediatrics (<12 months): The safety and efficacy of LIVMARLI in these pediatric patients have not been established.

Product Monograph

China¹

Cholestatic pruritus in ALGS patients one year
and older

Israel²

Cholestatic pruritus in ALGS patients one year
and older

South Korea³

Cholestatic pruritus in ALGS patients one year
and older

1. Approved through country regulatory agencies; commercialized by partner, CANbridge.

2. Approved through country regulatory agencies; commercialized by distributor partner, Neopharm.

3. Approved through country regulatory agencies; commercialized by partner, GC Pharma.

United States

Cholestatic pruritus in PFIC patients 12 months of age and older

LIVMARLI is not for use in patients with PFIC type 2 who have a severe defect in the bile salt export pump (BSEP) protein

Prescribing information and important safety information
European Union

For the treatment of PFIC in patients three months of age and older

SMPC