Germany· DE-A57-f31821aee2639a40
Fenizolan Kombi
A medicinal product containing fenticonazole nitrate, registered in Germany by Recordati Ireland Ltd..
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
- Fenticonazole Nitrate
- Manufacturer
- Recordati Ireland Ltd.
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- August 5, 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
Fenticonazole nitrate in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandGynoxinForfarm Sp. z o.o.
- BelgiumFentibel 20 mg/gRecordati Ireland
- SpainLAURIMIC 20 MG/G CREMALaboratorios Effik S.A.
- CzechiaLOMEXINRecordati S.P.A., Milano
- FranceFENTICONAZOLE BAILLEUL 2 %, crèmeLABORATOIRES BAILLEUL (LUXEMBOURG)
- IrelandGynoxin 200 mg Vaginal CapsulesRecordati Industria Chimica e Farmaceutica SpA
- United KingdomGynoxin 2% vaginal creamRecordati Pharmaceuticals Ltd
- NetherlandsLomexin 20 mg/g crème voor vaginaal gebruikRecordati Ireland Ltd. (Co. Cork)
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Lomexin
- Belgium · Fentibel, Gynoxin
- Bulgaria · Ломексин
- Cyprus · Lomexin
- Czechia · Lomexin
- Denmark · Lomexin
- Estonia · Lomexin
- Spain · Laurimic, Lomexin
- France · Fenticonazole Gerda, Fenticonazole Substipharm
- United Kingdom (Northern Ireland) · Gynoxin
- Greece · Lomexin
- Croatia · Lomexin
- Hungary · Gynoxin, Lomexin
- Ireland · Gynoxin, Lomexin
- Italy · Falvin, Lomexin
- Lithuania · Lomexin
- Luxembourg · Fentibel, Gynoxin
- Latvia · Lomexin
- Netherlands · Lomexin
- Poland · Gynoxin Optima, Gynoxin Uno
- Portugal · Lomexin
- Romania · Lomexin
- Slovenia · Lomexin
- Slovakia · Lomexin, Lomexin 2%
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/7804863b-b34b-46a3-a7e9-837f500334e3 GET /v1/drugs/7804863b-b34b-46a3-a7e9-837f500334e3?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": "Fenticonazole Nitrate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about fenticonazole nitrate.
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.