Germany· DE-A57-1ddd1447ece96331
Fucidine
A medicinal product containing fusidic acid hemihydrate, registered in Germany by Leo Pharma A/S.
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
- Fusidic Acid Hemihydrate
- Manufacturer
- Leo Pharma A/S
- 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
Fusidic acid hemihydrate in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandFucithalmicAmdipharm Limited
- BelgiumAffusine 20 mg/gWill Pharma
- NorwayFucithalmicAmdipharm
- IrelandFucidin 20 mg/g creamLeo Laboratories Limited
- CzechiaFUCITHALMICAMDIPHARM LIMITED, Dublin
- SwedenFucithalmic 1 % ÖgonsalvaAmdipharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 9 EEA countries. Names it is sold under:
- Bulgaria · Фуситалмик
- Greece · Fusidic Αcid Promopharma
- Ireland · Fucithalmic
- Italy · Fucithalmic
- Malta · Fucithalmic
- Norway · Fucithalmic
- Poland · Fusacid
- Romania · Fucithalmic
- Sweden · Fucithalmic
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/3df85f0d-a17b-4052-b2af-314e7b48adbf GET /v1/drugs/3df85f0d-a17b-4052-b2af-314e7b48adbf?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": "Fusidic Acid Hemihydrate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about fusidic acid hemihydrate.
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.