LYFNUA Film-coated tablet Ref.[51267] Active ingredients: Gefapixant

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Lyfnua 45 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Pink, 10 mm, round and convex tablet debossed with “777” on one side and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains gefapixant citrate equivalent to 45 mg of gefapixant.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Gefapixant

Gefapixant is a selective antagonist of the P2X3 receptor. P2X3 receptors are ATP-gated ion channels found on sensory C fibres of the vagus nerve in the airways. C fibres are activated in response to inflammation or chemical irritants. Blockade of ATP signalling through P2X3 receptors reduces excessive sensory-nerve activation and excessive cough induced by extracellular ATP.

List of Excipients

Tablet core:

Silica, collodial anhydrous (E551)
Crospovidone (E1202)
Hypromellose (E464)
Magnesium stearate (E470b)
Mannitol (E421)
Microcrystalline cellulose (E460)
Sodium stearyl fumarate

Film-coating:

Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Iron oxide red (E172)
Carnauba wax (E903)

Pack sizes and marketing

Opaque white PVC/PE/PVdC blisters with push through aluminium lidding foil. Packs of 28, 56 and 98 film-coated tablets in non-perforated blisters (14 tablets per card) and multipacks containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/21/1613/001
EU/1/21/1613/002
EU/1/21/1613/003
EU/1/21/1613/004

Drugs

Drug Countries
LYFNUA Estonia, Croatia, Ireland, Italy, Japan, Lithuania

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