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Netherlands· NL-bd2019c3c41d

ZTALMY 50 mg/ml orale suspensie

A ganaxolone product containing ganaxolon, registered in Netherlands by Immedica Pharma AB. The same ATC class is registered in 9 of our 19 countries.

ATC N03AX27

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedZTALMY 50 mg/ml orale suspensieATCN03AX27REGISTER NO.NL-bd2019c3c41dPACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ganaxolonAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
  • 6 of them publish a price we can compare per daily dose
Search ganaxolone products by name

Ganaxolone · ATC N03AX27

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
GANAXOLON
Manufacturer
Immedica Pharma AB
Country
Netherlands (NL)
ATC code
N03AX27
ATC class
Ganaxolone
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/23/1743

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.

All ganaxolone products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Ztalmy
  • 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 CBG-MEB (Netherlands). 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/da419b55-1e83-4b9e-83b5-d03d7c1ae49e
GET /v1/drugs/da419b55-1e83-4b9e-83b5-d03d7c1ae49e?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": "Suspensie voor oraal gebruik",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/ztalmy-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Ganaxolone",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp129092",
  "excipients": [
    "BENZOËZUUR (E 210)",
    "BENZYLALCOHOL (E 1519)",
    "CITROENZUUR 0-WATER (E 330)",
    "GLYCEROLMONOSTEARAAT (E 471)",
    "HYPROMELLOSE 2910 (3 - 15 mPa.s) (E 464)",
    "KERSENSMAAKSTOF",
    "MACROGOLSTEARAAT, TYPE I",
    "METHYLCELLULOSE (E 461)",
    "METHYLPARAHYDROXYBENZOAAT (E 218)",
    "NATRIUMBENZOAAT (E 211)",
    "NATRIUMLAURILSULFAAT",
    "POLYSORBAAT 65 (E 436)",
    "POLYVINYLALCOHOL (E 1203)",
    "PROPYLEENGLYCOL (E 1520)",
    "PROPYLPARAHYDROXYBENZOAAT",
    "SIMETICON",
    "SIMETICON EMULSIE",
    "SORBINEZUUR (E 200)",
    "SUCRALOSE (E 955)",
    "WATER, GEZUIVERD",
    "WATER, GEZUIVERD",
    "XANTHAANGOM (E 415)"
  ],
  "substances": [
    "GANAXOLON"
  ],
  "leaflet_url": null,
  "authorised_at": "2023/07/26",
  "procedure_number": "EMEA/H/C/005825",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/23/1743",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

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.

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