Belgium· BE-AMP-SAM665123-00
Zurzuvae 20 mg
A zuranolone product containing zuranolone, registered in Belgium by Biogen Netherlands. The same ATC class is registered in 8 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Zuranolone
- Manufacturer
- Biogen Netherlands
- Country
- Belgium (BE)
- ATC code
- N06AX31
- ATC class
- Zuranolone
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- IrelandZurzuvae 20 mg hard capsulesBiogen Netherlands B.V.
- IcelandZurzuvaeBiogen Netherlands B.V.
- NetherlandsZurzuvae 20 mg harde capsulesBiogen Netherlands B.V.
- PolandZurzuvaeBiogen Netherlands B.V.
- SwedenZurzuvae 20 mg Kapsel, hårdBiogen 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 FAMHP / AFMPS (Belgium). 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/63c9ec59-f1e1-4ddd-a705-e7e393a803c5 GET /v1/drugs/63c9ec59-f1e1-4ddd-a705-e7e393a803c5?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Zurzuvae 20 mg",
"name_fr": "Zurzuvae 20 mg",
"name_nl": "Zurzuvae 20 mg",
"amp_code": "SAM665123-00",
"strengths": [
"20.0000",
"20.0000"
],
"pack_count": 3,
"substances": [
"Zuranolone",
"Mannitol",
"Propylene Glycol",
"Sodium Stearyl Fumarate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Zuranolone",
"authorisation_numbers": [
"EU/1/25/1977/003",
"EU/1/25/1977/002",
"EU/1/25/1977/001"
]
}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.