VEOZA Film-coated tablet Ref.[107086] Active ingredients: Fezolinetant

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Product name and form

Veoza 45 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Round, light red tablets (approximately 7 mm diameter × 3 mm thickness), debossed with the company logo and ‘645’ on the same side.

Qualitative and quantitative composition

Each film-coated tablet contains 45 mg of fezolinetant.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fezolinetant

Fezolinetant is a non-hormonal selective neurokinin 3 (NK3) receptor antagonist. It blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron, which is postulated to restore the balance in KNDy neuronal activity in the thermoregulatory centre of the hypothalamus.

List of Excipients

Core tablet:

Mannitol (E421)
Hydroxypropyl cellulose (E463)
Low-substituted hydroxypropyl cellulose (E463a)
Microcrystalline cellulose (E460)
Magnesium stearate (E470b)

Film coating:

Hypromellose (E464)
Talc (E553b)
Macrogol (E1521)
Titanium dioxide (E171)
Iron oxide red (E172)

Pack sizes and marketing

PA/Aluminium/PVC/Aluminium unit dose blisters in cartons.

Pack sizes: 28 × 1, 30 × 1, and 100 × 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Marketing authorization dates and numbers

EU/1/23/1771/001
EU/1/23/1771/002
EU/1/23/1771/003

Drugs

Drug Countries
VEOZA Estonia, France, Croatia, Ireland, Lithuania, United Kingdom

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