Zurzuvae Biogen Netherlands B.V. · Authorised · ATC N06A
Therapeutic indication (EMA)
Zurzuvae is indicated for the treatment of postpartum depression (PPD) in adults following childbirth (see section 5.1).
Active substance
Zuranolone
- US FDA 1
- EMA 1
- Health Canada 2
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ZURZUVAE | 20MG; 25MG; 30MG | capsule · oral | BIOGEN | Prescription | 4 Aug 2023 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
Safety signals and safety-related labeling changes
- US FDA 20 Apr 2026 ZURZUVAE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 15 Jan 2026 PRAC signal: Suicidal ideation
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.