Belgium· BE-AMP-SAM661679-00
Ztalmy 50 mg/ml
A ganaxolone product containing ganaxolone, registered in Belgium by Marinus Pharmaceuticals Emerald. The same ATC class is registered in 9 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Ganaxolone
- Manufacturer
- Marinus Pharmaceuticals Emerald
- Country
- Belgium (BE)
- ATC code
- N03AX27
- ATC class
- Ganaxolone
- 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
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
- IcelandZtalmyImmedica Pharma AB
- NetherlandsZTALMY 50 mg/ml orale suspensieImmedica Pharma AB
- PolandZtalmyMarinus Pharmaceuticals Emerald Limited
- SwedenZTALMY 50 mg/ml Oral suspensionImmedica Pharma AB
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 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/3a84f0e7-f771-4e41-8faf-eaf0f9e34888 GET /v1/drugs/3a84f0e7-f771-4e41-8faf-eaf0f9e34888?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": "Oral suspension",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Ztalmy 50 mg/ml",
"name_fr": "Ztalmy 50 mg/ml",
"name_nl": "Ztalmy 50 mg/ml",
"amp_code": "SAM661679-00",
"strengths": [
"50.0000",
"50.0000",
"0.0007",
"0.0007",
"0.0002",
"0.0002",
"1.0200",
"1.0200",
"0.2000",
"0.2000",
"0.9200",
"0.9200"
],
"pack_count": 2,
"substances": [
"Ganaxolone",
"Benzoic Acid",
"Benzyl Alcohol",
"Methyl Parahydroxybenzoate",
"Propyl Parahydroxybenzoate",
"Sodium Benzoate",
"Sodium Laurilsulfate",
"Sorbic Acid",
"Polysorbate",
"Artificial Cherry Flavour Containing Benzyl Alcohol and Propylene Glycol"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Ganaxolone",
"authorisation_numbers": [
"EU/1/23/1743/002",
"EU/1/23/1743/001"
]
}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.