🇪🇺 ELINZANETANT in European Union

EMA authorised ELINZANETANT on 17 November 2025

Marketing authorisation

EMA — authorised 17 November 2025

  • Application: EMEA/H/C/006298
  • Marketing authorisation holder: Bayer AG
  • Local brand name: Lynkuet
  • Indication: Treatment of moderate to severe vasomotor symptoms (VMS).
  • Status: approved

The European Medicines Agency (EMA) has approved Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS). This approval was granted to Bayer AG on 17 November 2025. Vasomotor symptoms, such as hot flashes and night sweats, are common in menopausal women and can significantly impact their quality of life. Lynkuet is the first treatment approved in the European Union for this indication.

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ELINZANETANT in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is ELINZANETANT approved in European Union?

Yes. EMA authorised it on 17 November 2025.

Who is the marketing authorisation holder for ELINZANETANT in European Union?

Bayer AG holds the EU marketing authorisation.