LIVMARLI Oral solution Ref.[50565] Active ingredients: Maralixibat

Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Mirum Pharmaceuticals International B.V., Kingsfordweg 151, 1043 GR Amsterdam, Netherlands

Product name and form

Livmarli 9.5 mg/mL oral solution.

Pharmaceutical Form
Oral solution. Clear, colourless to light-yellow liquid.

Qualitative and quantitative composition

Each mL of solution contains maralixibat chloride equivalent to 9.5 mg maralixibat.

Excipient with known effect: Each mL of oral solution contains 364.5 mg propylene glycol (E1520).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Maralixibat	Maralixibat is a minimally absorbed, reversible, potent, selective inhibitor of the ileal bile acid transporter (IBAT). Maralixibat acts locally in the distal ileum to decrease the reuptake of bile acids and increase the clearance of bile acids through the colon, reducing the concentration of bile acids in the serum.

List of Excipients
Propylene glycol (E1520) Disodium edetate Sucralose Grape flavour Purified water

Pack sizes and marketing

30 mL amber-coloured PET bottle with a preinstalled LDPE adapter and a HDPE child-resistant closure with a foam liner, containing 30 mL oral solution.

Pack size:

Each pack contains one 30 mL bottle and is co-packaged with three oral repeated-use syringes (0.5 mL, 1 mL and 3 mL) with the following graduations:

0.5 mL polypropylene syringe with a white plunger: numbers for each 0.1 mL, major hash marks for 0.05 mL increments, and minor hash marks for 0.01 mL increments.
1 mL polypropylene syringe with a white plunger: numbers for each 0.1 mL increment.
3 mL polypropylene syringe with a white plunger: numbers for each 0.5 mL increment, and hash marks for each 0.25 mL increment between 0.5 mL and 3 mL.

Marketing authorization holder

Mirum Pharmaceuticals International B.V., Kingsfordweg 151, 1043 GR Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/22/1704/001

Drugs

Drug	Countries
LIVMARLI	Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Romania, United States

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