Ireland· IE-PA-PA0815/005/001
Ospolot 20 mg/ml Oral Suspension
A sultiame product containing sultiame, registered in Ireland by Desitin Arzneimittel GmbH. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Sultiame is registered in 12 of 19 countries.
Countries holding a registration under ATC N03AX03 (sultiame), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 6 of them publish a price we can compare per daily dose
Sultiame · ATC N03AX03
12 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
Price per daily dose
What a daily dose of sultiame costs, country by country.
Normalised to the WHO defined daily dose (0.4 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Sultiame · price per daily dose (0.4 g)
USD · FX 28 Sept 2026
- CH Switzerland$4.91
The record
At a glance
HPRA (Ireland)- Active substance
- Sultiame
- Manufacturer
- Desitin Arzneimittel GmbH
- Country
- Ireland (IE)
- ATC code
- N03AX03
- ATC class
- Sultiame
- Defined daily dose
- 0.4 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA0815/005/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
12 interactions on record for sultiame.
Mechanism, severity and management for each pair, from a commercially licensed source — included with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Sultiame · interactions on record
12 records
12 more interactions with mechanism and management, from a commercially licensed source.
Sign in to checkSame medicine, other countries
Sultiame in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaOSPOLOTDesitin Arzneimittel GmbH, Hamburg
- SpainOSPOLOT 20 MG/ML SUSPENSIÓN ORALDesitin Arzneimittel Gmbh
- FinlandOspolotDesitin Arzneimittel GmbH
- NetherlandsOspolot 20 mg/ml suspensie voor oraal gebruikDesitin Arzneimittel GmbH
- NorwayOspolotDesitin Arzneimittel GmbH
- PolandSultiame DesitinDesitin Arznemittel GmbH
- BelgiumOspolot 20 mg/mlDesitin Arzneimittel
- SwedenOspolot 20 mg/ml Oral suspensionDesitin Arzneimittel GmbH
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Austria · Ospolot, Sultiam Neuraxpharm
- Belgium · Ospolot
- Czechia · Ospolot
- Germany · Ospolot, Sultiam Neuraxpharm
- Denmark · Ospolot, Ospolot-Tab
- Estonia · Ospolot
- Spain · Ospolot
- Finland · Ospolot
- United Kingdom (Northern Ireland) · Ospolot
- Hungary · Ospolot
- Italy · Ospolot
- Luxembourg · Ospolot
- Netherlands · Ospolot
- Norway · Ospolot
- Poland · Sultiame Desitin
- Portugal · Ospolot
- Romania · Ospolot
- Sweden · Ospolot
- Slovakia · Ospolot
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/cb554194-cd10-4b09-99ce-8d137ae19a77 GET /v1/drugs/cb554194-cd10-4b09-99ce-8d137ae19a77?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",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"N03AX03"
],
"strength": null,
"pa_number": "PA0815/005/001",
"substances": [
"Sultiame"
],
"legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
"market_info": "Not marketed",
"authorised_at": "25/10/2024",
"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 sultiame.
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.