Belgium· BE-AMP-SAM662542-00

Ospolot 20 mg/ml

A sultiame product containing sultiame, registered in Belgium by Desitin Arzneimittel. The same ATC class is registered in 12 of our 19 countries.

ATC N03AX03

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOspolot 20 mg/mlATCN03AX03REGISTER NO.BE-AMP-SAM662542-00PACKS LISTED0CHECKEDSeptember 26, 2026

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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
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.

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
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Sultiame
Manufacturer
Desitin Arzneimittel
Country
Belgium (BE)
ATC code
N03AX03
ATC class
Sultiame
Defined daily dose
0.4 g, O
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.

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 check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same 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.

All sultiame products

Authorised across Europe · EMA

The same active substance is authorised in 19 EEA countries. Names it is sold under:

  • Austria · Ospolot, Sultiam Neuraxpharm
  • Czechia · Ospolot
  • Germany · Ospolot, Sultiam Neuraxpharm
  • Denmark · Ospolot, Ospolot-Tab
  • Estonia · Ospolot
  • Spain · Ospolot
  • Finland · Ospolot
  • United Kingdom (Northern Ireland) · Ospolot
  • Hungary · Ospolot
  • Ireland · 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 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/b3cf8e86-5a33-409f-9226-176f0783a0d9
GET /v1/drugs/b3cf8e86-5a33-409f-9226-176f0783a0d9?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": "Ospolot 20 mg/ml",
  "name_fr": "Ospolot 20 mg/ml",
  "name_nl": "Ospolot 20 mg/ml",
  "amp_code": "SAM662542-00",
  "strengths": [
    "20.0000",
    "20.0000",
    "6.0000",
    "0.0100",
    "2.0000",
    "2.3000",
    "0.6000"
  ],
  "pack_count": 2,
  "substances": [
    "Sultiame",
    "Dipotassium Hydrogen Phosphate",
    "Docusate Sodium",
    "Sodium Dihydrogen Phosphate Dihydrate",
    "Sodium Methyl Parahydroxybenzoate",
    "Sodium Propyl Parahydroxybenzoate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Sultiame",
  "authorisation_numbers": [
    "BE662542"
  ]
}

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.