ZOKINVY Hard capsule Ref.[50133] Active ingredients: Lonafarnib

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: EigerBio Europe Ltd., 1 Castlewood Avenue, Rathmines, D06 H685, Ireland

Product name and form

Zokinvy 50 mg hard capsules.

Zokinvy 75 mg hard capsules.

Pharmaceutical Form

Hard capsule (capsule).

Zokinvy 50 mg hard capsules: Size 4 hard capsule (5 mm x 14 mm), opaque yellow with “LNF” and “50” printed in black.

Zokinvy 75 mg hard capsules: Size 3 hard capsule (6 mm x 16 mm), opaque light orange with "LNF and “75” printed in black.

Qualitative and quantitative composition

Zokinvy 50 mg hard capsules: Each capsule contains 50 mg lonafarnib.

Zokinvy 75 mg hard capsules: Each capsule contains 75 mg lonafarnib.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lonafarnib

Lonafarnib is a disease modifying agent that prevents farnesylation, thereby reducing the accumulation of aberrant progerin and progerin-like proteins in the cell’s inner nuclear membrane. This results in maintaining cell integrity and normal function.

List of Excipients

Capsule contents:

Povidone
Poloxamer
Croscarmellose sodium
Silica, colloidal anhydrous
Magnesium stearate

Capsule shell:

Gelatin (E171)
Titanium dioxide
Yellow iron oxide (E172)
Red iron oxide (E172) (75 mg capsules only)
Sunflower lecithin (E322)

Black ink:

Shellac
Iron oxide black (E172)
Propylene glycol
Ammonia solution
Potassium hydroxide

Pack sizes and marketing

HDPE bottle, containing desiccant in a cannister and capsules, with induction seal and polypropylene cap. Pack size of 30 hard capsules.

Marketing authorization holder

EigerBio Europe Ltd., 1 Castlewood Avenue, Rathmines, D06 H685, Ireland

Marketing authorization dates and numbers

Zokinvy 50 mg hard capsules: EU/1/22/1660/001
Zokinvy 75 mg hard capsules: EU/1/22/1660/002

Drugs

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

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