Lynkuet (elinzanetant)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- elinzanetant
- Company
- Bayer AG
- Status
- Authorised
- Therapeutic area
- Hot Flashes; Menopause; Breast Neoplasms
- CHMP opinion
- Thu 18 Sep 2025
- EU approval
- Mon 17 Nov 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006298
- ATC
- G02CX07
- Official record
- www.ema.europa.eu
Indication
Treatment of moderate to severe vasomotor symptoms (VMS).
Regulatory milestones
Mon 17 Nov 2025🇪🇺 EU approval (EC decision)
Lynkuet (elinzanetant) approved in the EU
Marketing authorisation to Bayer AG; Additional monitoring · source
Fri 24 Oct 2025🇺🇸 FDA approval
FDA approves Lynkuet (elinzanetant), a new medicine
Bayer Hlthcare; NDA219469; New molecular entity; capsule · source
Same substance in other markets
- 🇺🇸 Lynkuet Approved · Bayer Hlthcare
Follow Lynkuet
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.