Germany· DE-A57-604b017611f31d08
Biofanal
A medicinal product containing nystatin, registered in Germany by Dr. Pfleger Arzneimittel Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Nystatin
- Manufacturer
- Dr. Pfleger Arzneimittel Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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.
- United StatesKLAYESTAEpic Pharma, LLC
- United KingdomNystamont 100,000units/ml oral suspensionRosemont Pharmaceuticals Ltd
- NorwayBiofanalPfleger
- CanadaJAMP-NYSTATIN ORAL SUSPENSION USPJAMP PHARMA CORPORATION
- SwedenNystatin Ebb 100000 IE/ml Oral suspensionEbb Medical AB
- PolandNyscandinAflofarm Farmacja Polska Sp. z o.o.
- FinlandMycostatinBristol-Myers Squibb Ab
- NetherlandsNystatine ERC 100.000 E/ml, suspensie voor oraal gebruikEuro Registratie Collectief B.V.
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Candio, Mycostatin
- Belgium · Nilstat, Skandyra
- Bulgaria · Нистатин Абр, Нистатин Актавис
- Cyprus · Nystamysyn, Restatin
- Czechia · Fungicidin Léčiva
- 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 EMA Article 57 (European Union). 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/f6f0e59e-3fe5-44a0-92b9-1b36339908f2 GET /v1/drugs/f6f0e59e-3fe5-44a0-92b9-1b36339908f2?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.
{
"pzn": null,
"route": "Cutaneous Use ,Vaginal Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Nystatin",
"atc_from_source": null,
"authorisation_country": "Germany"
}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.