Poland· PL-100419960
Lotemax 0,5%
A loteprednol product containing loteprednoli etabonas, registered in Poland by Delfarma Sp. z o.o.. The same ATC class is registered in 6 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Loteprednol is registered in 6 of 19 countries.
Countries holding a registration under ATC S01BA14 (loteprednol), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 3 of them publish a price we can compare per daily dose
Loteprednol · ATC S01BA14
6 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Ireland
- Polandprice
- United Kingdom
The record
At a glance
URPL (Poland)- Active substance
- Loteprednoli etabonas
- Manufacturer
- Delfarma Sp. z o.o.
- Country
- Poland (PL)
- ATC code
- S01BA14
- ATC class
- Loteprednol
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin05909991402945
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
57 interactions on record for loteprednol.
Graded by severity as the source publishes them — 16 moderate. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Loteprednol · interactions on record
57 records
- 16 moderate
- 41 info
Most severe, free to view
- MiconazoleA07AC01moderate
- KetoconazoleH02CA03moderate
- ErythromycinJ01FA01moderate
- ClarithromycinJ01FA09moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Loteprednol 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
- CzechiaLOTEPREDNOL OLIKLAOlikla s.r.o., Kostelec nad Černými Lesy
- GermanyLotemaxDr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh
- 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
- Germany · Lotemax
- Estonia · Lotemax
- United Kingdom (Northern Ireland) · Lotemax
- Greece · Lotemax
- Ireland · Lotemax
- Italy · Lotemax, Nolok
- Lithuania · 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 URPL (Poland). 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/035c7aeb-cee9-4224-b6a1-eb0fb299291e GET /v1/drugs/035c7aeb-cee9-4224-b6a1-eb0fb299291e?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.
{
"form": "Krople do oczu, zawiesina",
"source": "urpl",
"strength": "0,5%",
"packaging": "05909991402945 ¦ Rp ¦ 132572\n1 butelka 5 ml",
"substance": "Loteprednolu etabonian 0,5%",
"common_name": "Loteprednoli etabonas",
"pl_product_id": "100419960",
"pozwolenie_nr": "185/19",
"auth_procedure": "IR",
"authorisation_validity": "2029-05-07"
}See everything about loteprednol.
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.