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fezolinetant

Veoza · ATC code G02CX06

Key facts
Active substance
fezolinetant
ATC code
G02CX06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Veoza 45 mg film-coated tablets
Marketing authorisation holder
Astellas Pharma Europe B.V.
Information as of
2026-10-27

Key facts

Fezolinetant is a non-hormonal neurokinin-3 receptor antagonist (Veoza film-coated tablets). It is used to treat moderate to severe vasomotor symptoms (hot flushes) associated with menopause.

What it is used for

  • Moderate to severe vasomotor symptoms (VMS) associated with menopause

Dosing

  • 45 mg once daily at about the same time, with or without food; swallow tablets whole
  • Benefit of long-term treatment should be assessed periodically
  • Take a missed dose as soon as possible unless less than 12 hours remain before the next dose
  • Mild hepatic impairment (Child-Pugh A) and mild or moderate renal impairment: no dose modification
  • Not recommended in Child-Pugh B or C or severe renal impairment (eGFR less than 30); no dose recommendation for women starting over 65 years

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Concomitant use of moderate or strong CYP1A2 inhibitors
  • Known or suspected pregnancy

Important warnings

  • Drug-induced liver injury: liver function tests before starting, monthly for the first three months, and if symptoms occur
  • Do not start if ALT or AST is ≥ 2 x ULN or total bilirubin is elevated; discontinue for defined transaminase elevations
  • Careful diagnosis and complete medical history before starting; periodic check-ups during treatment
  • Active liver disease and moderate/severe hepatic impairment were not studied

Side effects

  • Most frequent: diarrhoea (3.2%) and insomnia (3.0%)
  • Also common: abdominal pain, increased ALT and AST
  • Most serious in studies: one event of endometrial adenocarcinoma (0.1%)

Interactions

  • Fezolinetant is primarily metabolised by CYP1A2
  • Moderate or strong CYP1A2 inhibitors (e.g. ethinyl oestradiol contraceptives, mexiletine, enoxacin, fluvoxamine) raise exposure and are contraindicated

Pregnancy and breastfeeding

  • Pregnancy: contraindicated; perimenopausal women of childbearing potential should use effective, preferably non-hormonal, contraception
  • Breast-feeding: not indicated; excretion in human milk unknown

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • VeozaAstellas Pharma Europe B.V. · EMEA/H/C/005851

Source: European Medicines Agency (EMA), product information

Turkey

  • VeozaASTELLAS PHARMA İLAÇ TİC. VE SAN. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Veoza
Liechtenstein
Veoza
Norway
Veoza

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

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Sources

  1. European Medicines Agency. Veoza – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/veoza-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.