Ireland· IE-PA-EU/1/25/1977/001-003
Zurzuvae 20 mg hard capsules
A zuranolone product containing zuranolone, registered in Ireland by Biogen Netherlands B.V.. The same ATC class is registered in 8 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Zuranolone is registered in 8 of 19 countries.
Countries holding a registration under ATC N06AX31 (zuranolone), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 5 of them publish a price we can compare per daily dose
Zuranolone · ATC N06AX31
8 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Zuranolone
- Manufacturer
- Biogen Netherlands B.V.
- Country
- Ireland (IE)
- ATC code
- N06AX31
- ATC class
- Zuranolone
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/1977/001-003
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Zuranolone in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaZURZUVAEBiogen Netherlands B.V., Badhoevedorp
- United StatesZURZUVAEBiogen MA Inc.
- IcelandZurzuvaeBiogen Netherlands B.V.
- BelgiumZurzuvae 20 mgBiogen Netherlands
- PolandZurzuvaeBiogen Netherlands B.V.
- SwedenZurzuvae 20 mg Kapsel, hårdBiogen Netherlands B.V.
- NetherlandsZurzuvae 20 mg harde capsulesBiogen Netherlands B.V.
- FinlandZurzuvaeBiogen Netherlands B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Zurzuvae
- Liechtenstein · Zurzuvae
- Norway · Zurzuvae
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/57e43dca-a6c0-4dbe-84b9-d24d8b7f77a3 GET /v1/drugs/57e43dca-a6c0-4dbe-84b9-d24d8b7f77a3?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Capsule, hard",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"N06AX31"
],
"strength": null,
"pa_number": "EU/1/25/1977/001-003",
"substances": [
"Zuranolone"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "17/09/2025",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about zuranolone.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.