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Ireland· IE-PA-PA1245/001/001

Lotemax 0.5% w/v eye drops, suspension

A loteprednol product containing loteprednol etabonate, registered in Ireland by Dr. Gerhard Mann, chem.-pharm. Fabrik GmbH. The same ATC class is registered in 6 of our 19 countries.

ATC S01BA14

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedLotemax 0.5% w/v eye drops, suspensionATCS01BA14REGISTER NO.IE-PA-PA1245/001/001PACKS LISTED1CHECKEDSeptember 28, 2026

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: Ireland, from HPRA (Ireland)
  • 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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Loteprednol etabonate
Manufacturer
Dr. Gerhard Mann, chem.-pharm. Fabrik GmbH
Country
Ireland (IE)
ATC code
S01BA14
ATC class
Loteprednol
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA1245/001/001

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All loteprednol products

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
  • 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 HPRA (Ireland). 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/5af0dab3-b740-4566-a2b7-0252a8ed5e17
GET /v1/drugs/5af0dab3-b740-4566-a2b7-0252a8ed5e17?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": "Eye drops, suspension",
  "routes": [
    "Ocular use"
  ],
  "source": "hpra",
  "atc_all": [
    "S01BA",
    "S01BA14"
  ],
  "strength": null,
  "pa_number": "PA1245/001/001",
  "substances": [
    "Loteprednol etabonate"
  ],
  "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "10/11/2006",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

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.