Germany· DE-A57-3835cb060f044a21
Batrafen
A medicinal product containing ciclopirox olamine, registered in Germany by Zentiva Pharma 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
- Ciclopirox Olamine
- Manufacturer
- Zentiva Pharma 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
Ciclopirox olamine in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesCiclopirox olaminePadagis Israel Pharmaceuticals Ltd
- FranceCICLOPIROX OLAMINE ARROW 1,5 %, shampooingARROW GENERIQUES
- CzechiaBATRAFENOpella Healthcare Czech s.r.o., Praha
- BelgiumCiclopirox Olamine Polichem 10 mg/mlPolichem
- CanadaLOPROXBAUSCH HEALTH, CANADA INC.
- IrelandStieprox 15 mg/g ShampooGlaxoSmithKline (Ireland) Limited
- FinlandSebiproxGlaxoSmithKline Oy
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Cyprus · Mycomycen
- Czechia · Batrafen, Dafnegin
- Spain · Capitec, Ciclochem
- France · Ciclopirox Olamine Arrow, Ciclopirox Olamine Biogaran
- Greece · Mycomycen, Neo-Botacreme
- Croatia · Oxolam
- Hungary · Batrafen
- Ireland · Stieprox
- Italy · Bioginal, Dafnegin
- Luxembourg · Mycoster
- Malta · Mycoskin
- Netherlands · Loprox
- Poland · Ciclopirox Ziaja, Dafnegin
- Portugal · Mycoster
- Slovakia · Batrafen
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/5afc2631-e920-45cb-8a50-15c4a807c615 GET /v1/drugs/5afc2631-e920-45cb-8a50-15c4a807c615?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",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Ciclopirox Olamine",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about ciclopirox olamine.
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.