Ireland· IE-PA-PA1142/014/001
Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension
A hydrocortison und antiinfektiva product containing gentamicin sulfate + hydrocortisone acetate, registered in Ireland by Amdipharm Limited. The same ATC class is registered in 6 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Hydrocortison und antiinfektiva is registered in 6 of 19 countries.
Countries holding a registration under ATC S02CA03 (hydrocortison und antiinfektiva), 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
Hydrocortison und antiinfektiva · ATC S02CA03
6 / 19 countries
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Gentamicin sulfate + HYDROCORTISONE ACETATE
- Manufacturer
- Amdipharm Limited
- Country
- Ireland (IE)
- ATC code
- S02CA03
- ATC class
- Hydrocortison und Antiinfektiva
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA1142/014/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under S02CA03
Hydrocortison und antiinfektiva, as other registers publish it.
- NetherlandsBacicoline-B, poeder voor oordruppelsDaleco Pharma b.v.
- IcelandCifloxNovartis Healthcare A/S
- DenmarkCifloxNovartis Healthcare A/S
- SwitzerlandCiproxin HC
- SwitzerlandCiproxin HC, Ohrentropfen, SuspensionNovartis Pharma Schweiz AG
- FinlandCiproxin-HydrocortisonParanova Oy
- FinlandCiproxin-HydrocortisonOrifarm Oy
- FinlandCiproxin-HydrocortisonNovartis Finland Oy
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- United Kingdom (Northern Ireland) · Gentamicin And Hydrocortisone Acetate Amdipharm Uk Limited, Gentisone Hc
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/dc237b66-3394-414a-9ed1-e2c854ad429a GET /v1/drugs/dc237b66-3394-414a-9ed1-e2c854ad429a?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": "Ear drops, suspension",
"routes": [
"Auricular use"
],
"source": "hpra",
"atc_all": [
"S02CA",
"S02CA03"
],
"strength": null,
"pa_number": "PA1142/014/001",
"substances": [
"Gentamicin sulfate",
"HYDROCORTISONE ACETATE"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "18/05/1995",
"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 hydrocortison und antiinfektiva.
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.