Ireland· IE-PA-PA0126/357/002
Brolene 0.15 % w/w Eye Ointment
A dibrompropamidine product containing dibrompropamidine isetionate, registered in Ireland by Clonmel Healthcare Ltd. The same ATC class is registered in 2 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Dibrompropamidine is registered in 2 of 19 countries.
Countries holding a registration under ATC S01AX14 (dibrompropamidine), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
Dibrompropamidine · ATC S01AX14
2 / 19 countries
- Ireland
- United Kingdom
The record
At a glance
HPRA (Ireland)- Active substance
- Dibrompropamidine isetionate
- Manufacturer
- Clonmel Healthcare Ltd
- Country
- Ireland (IE)
- ATC code
- S01AX14
- ATC class
- Dibrompropamidine
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA0126/357/002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dibrompropamidine in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Cyprus · Golden Eye
- United Kingdom (Northern Ireland) · Brolene, Brulidine
- Malta · Golden Eye
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/b048ec06-ef86-43c7-8bda-cfa009ae05db GET /v1/drugs/b048ec06-ef86-43c7-8bda-cfa009ae05db?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 ointment",
"routes": [
"Ocular use"
],
"source": "hpra",
"atc_all": [
"S01AX",
"S01AX14"
],
"strength": null,
"pa_number": "PA0126/357/002",
"substances": [
"Dibrompropamidine isetionate"
],
"legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "01/04/1983",
"dispensing_status": "Product not subject to medical prescription",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about dibrompropamidine.
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.