Germany· DE-A57-391657030849a341
Lotemax
A medicinal product containing loteprednol etabonate, registered in Germany by Dr. Gerhard Mann Chem.-Pharm. Fabrik 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
- Loteprednol Etabonate
- Manufacturer
- Dr. Gerhard Mann Chem.-Pharm. Fabrik 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
Loteprednol etabonate in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesAlrexBausch & Lomb Incorporated
- CanadaALREXBAUSCH & LOMB INC
- PolandLotemax 0,5%InPharm Sp. z o.o.
- CzechiaLOTEPREDNOL OLIKLAOlikla s.r.o., Kostelec nad Černými Lesy
- BelgiumLotemax 5 mg/mlBausch & Lomb Pharma
- IrelandLotemax 0.5% w/v eye drops, suspensionDr. Gerhard Mann, chem.-pharm. Fabrik GmbH
Authorised across Europe · EMA
The same active substance is authorised in 13 EEA countries. Names it is sold under:
- Austria · Lotemax
- Cyprus · Lotemax
- Czechia · Loteprednol Olikla
- Estonia · Lotemax
- United Kingdom (Northern Ireland) · Lotemax
- Greece · Lotemax
- Ireland · Lotemax
- Italy · Lotemax, Nolok
- Lithuania · Lotemax
- Poland · Lotemax
- Portugal · Xafex
- Slovenia · Lotemax
- Slovakia · Lotemax, Loteprednol Olikla
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/03cd908c-59a8-4f5e-8190-80601b582ebf GET /v1/drugs/03cd908c-59a8-4f5e-8190-80601b582ebf?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": "Ocular Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Loteprednol Etabonate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about loteprednol etabonate.
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.