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Belgium· BE-AMP-SAM097587-00

Nystatine Labaz 100.000 IU/g

A nystatin product containing nystatin, registered in Belgium by Sanofi Belgium. The same ATC class is registered in 10 of our 19 countries.

ATC D01AA01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedNystatine Labaz 100.000 IU/gATCD01AA01REGISTER NO.BE-AMP-SAM097587-00PACKS LISTED0CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about nystatinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Nystatin is registered in 10 of 19 countries.

Countries holding a registration under ATC D01AA01 (nystatin), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 7 of them publish a price we can compare per daily dose
Search nystatin products by name

Nystatin · ATC D01AA01

10 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Finlandprice
  • Germany
  • Italyprice
  • Norwayprice
  • Switzerlandprice
  • United Kingdom
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Nystatin
Manufacturer
Sanofi Belgium
Country
Belgium (BE)
ATC code
D01AA01
ATC class
Nystatin
Defined daily dose
250 TSD, E
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

Nystatin in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All nystatin products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Candio, Mycostatin
  • Bulgaria · Нистатин Абр, Нистатин Актавис
  • Cyprus · Nystamysyn, Restatin
  • Czechia · Fungicidin Léčiva
  • Germany · Adiclair, Biofanal
  • Denmark · Nystatin Orifarm, Nystimex
  • Spain · Mycostatin
  • Finland · Nystatin Orifarm, Nystimex
  • France · Mycostatine
  • United Kingdom (Northern Ireland) · Nystan, Nystatin Vygoris
  • Greece · Nystamysyn
  • Croatia · Pronigyn
  • Hungary · Nystatin Pannonpharma
  • Ireland · Mycostatin (Ready Mixed)
  • Iceland · Nystatin Orifarm, Nystimex
  • Italy · Mycostatin
  • Lithuania · Nystatin Actavis
  • Luxembourg · Biofanal Kombi, Candio-Hermal
  • Netherlands · Nystatine Labaz, Nystatine Rph
  • Norway · Nystatin Orifarm, Nystimex
  • Poland · Nyscandin, Nystapol
  • Portugal · Mycostatin
  • Romania · Nistatina Atb, Nistatină Atb
  • Sweden · Nystatin Evolan, Nystatin Orifarm
  • Slovenia · Pronigyn
  • Slovakia · Fungicidin Léčiva, Nystatin Galvex

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/cb134a4d-5b47-4934-b421-452e26f61f7c
GET /v1/drugs/cb134a4d-5b47-4934-b421-452e26f61f7c?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": "Ointment",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Nystatine Labaz 100.000 IU/g",
  "name_fr": "Nystatine Labaz 100.000 IU/g",
  "name_nl": "Nystatine Labaz 100.000 IU/g",
  "amp_code": "SAM097587-00",
  "strengths": [
    "100000.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Nystatin"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Nystatin",
  "authorisation_numbers": [
    "BE097587"
  ]
}
API referenceMCP serverPlans

See everything about nystatin.

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.

Try it freeOpen in the console