LUPKYNIS Soft capsule Ref.[50195] Active ingredients: Voclosporin

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT Amsterdam, Netherlands

Product name and form

Lupkynis 7.9 mg soft capsules.

Pharmaceutical Form

Soft capsule (capsule).

Pink/orange oval soft capsules measuring approximately 13 mm × 6 mm.

Qualitative and quantitative composition

Each soft capsule contains 7.9 mg of voclosporin.

Excipients with known effect: Each soft capsule contains 21.6 mg ethanol and 28.7 mg sorbitol.

Lupkynis may contain trace amounts of soya lecithin, see section 4.4.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Voclosporin

Voclosporin is a calcineurin-inhibitor immunosuppressant that inhibits calcineurin in a dose-dependent manner. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens.
List of Excipients

Capsule content:

Ethanol
Vitamin E (E307) polyethylene glycol succinate (tocofersolan)
Polysorbate 40
Medium-chain triglycerides

Capsule shell:

Gelatin
Sorbitol
Glycerin
Purified water
Titanium dioxide (E171)
Iron oxide, red (E172)
Iron oxide, yellow (E172)

Processing aids:

Soya lecithin

Pack sizes and marketing

Soft capsules are available in cold-formed aluminium blisters, laminated backing and lidding materials that are thermo-sealed together. Each blister contains 18 soft capsules. One carton contains 180 or 576 soft capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT Amsterdam, Netherlands

Marketing authorization dates and numbers

Date of first authorisation: 15 September 2022

Drugs

Drug Countries
LUPKYNIS Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom, United States
 
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