Iceland· IS-EU/1/23/1743/001-002
Ztalmy
A ganaxolone product containing ganaxolonum inn, registered in Iceland by Immedica Pharma AB. The same ATC class is registered in 9 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Ganaxolone is registered in 9 of 19 countries.
Countries holding a registration under ATC N03AX27 (ganaxolone), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 6 of them publish a price we can compare per daily dose
Ganaxolone · ATC N03AX27
9 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- United Statesprice
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- Ganaxolonum INN
- Manufacturer
- Immedica Pharma AB
- Country
- Iceland (IS)
- ATC code
- N03AX27
- ATC class
- Ganaxolone
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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
Ganaxolone in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaZTALMYImmedica Pharma AB, Stockholm
- SpainZTALMY 50 MG/ML SUSPENSION ORALImmedica Pharma Ab
- FinlandZTALMYImmedica Pharma AB
- IrelandZTALMY 50 mg/mL oral suspensionMarinus Pharmaceuticals Emerald Limited
- NetherlandsZTALMY 50 mg/ml orale suspensieImmedica Pharma AB
- PolandZtalmyMarinus Pharmaceuticals Emerald Limited
- SwedenZTALMY 50 mg/ml Oral suspensionImmedica Pharma AB
- BelgiumZtalmy 50 mg/mlMarinus Pharmaceuticals Emerald
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Liechtenstein · Ztalmy
- Norway · Ztalmy
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 Icelandic Medicines Agency (Iceland). 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/559d8000-a82f-4dde-b649-fa74ea523f7f GET /v1/drugs/559d8000-a82f-4dde-b649-fa74ea523f7f?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": "Mixtúra, dreifa",
"source": "lyfjastofnun",
"atc_raw": "N03AX27",
"marketed": false,
"strength": "50 mg/ml",
"ma_number": "EU/1/23/1743/001-002",
"substance": "Ganaxolonum INN",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í taugasjúkdómum og í taugasjúkdómum barna.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "45133"
}See everything about ganaxolone.
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.