LYNKUET Soft capsule Ref.[116026] Active ingredients: Elinzanetant

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Bayer AG, 51368 Leverkusen, Germany

Product name and form

Lynkuet 60 mg soft capsules.

Pharmaceutical Form

Soft capsule (capsule).

Opaque red, oblong, approximately 24 mm long and 11 mm in diameter, with white printing of "EZN60".

Qualitative and quantitative composition

Each soft capsule contains 60 mg elinzanetant.

Excipient with known effect:

Each soft capsule contains 71 mg sorbitol (E420).

For the full list of excipients, see section 6.1.

Active Ingredient

Elinzanetant is a non-hormonal, selective neurokinin 1 (NK-1) and 3 (NK-3) receptors antagonist. It blocks NK-1 and NK-3 receptors signalling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons, which is postulated to normalise neuronal activity involved in thermo- and sleep regulation.

List of Excipients

Capsule filling:

All-rac-α-tocopherol (E307)
Caprylocaproyl macrogolglycerides
Glycerol monocaprylocaprate
Glycerol mono-oleate (E471)
Polysorbate 80 (E433)

Capsule shell:

Gelatin
Sorbitol, liquid, partially dehydrated (E420) - glycerol (E422) blend
Iron oxide red (E172)
Iron oxide yellow (E172)
Medium-chain triglycerides
Phosphatidyl choline solution 53% in medium-chain triglycerides
Titanium dioxide (E171)

Printing ink:

Macrogol 400 (E1521)
Polyvinyl acetate phthalate
Propylene glycol (E1520)
Titanium dioxide (E171)

Pack sizes and marketing

PVC/PCTFE-Aluminium/PET/paper blister containing 12 soft capsules (6 × 2 as unit dose).

Each pack contains 24 or 60 soft capsules.

Each multipack contains 180 (3 packs of 60) soft capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

Marketing authorization dates and numbers

EU/1/25/1991/001 - Lynkuet 60 mg - 24 soft capsules
EU/1/25/1991/002 - Lynkuet 60 mg - 60 soft capsules
EU/1/25/1991/003 - Lynkuet 60 mg - 180 soft capsules

Drugs

Drug Countries
LYNKUET Austria, Estonia, Lithuania, United States

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