Zurzuvae (zuranolone)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- zuranolone
- Company
- Biogen Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Depression, Postpartum
- CHMP opinion
- Thu 24 Jul 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006488
- ATC
- N06A
- Official record
- www.ema.europa.eu
Indication
Zurzuvae is indicated for the treatment of postpartum depression (PPD) in adults following childbirth (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
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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.