Ireland· IE-PA-PA1107/012/001
Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injection
A tropicamid, kombinationen product containing tropicamide + phenylephrine hydrochloride + lidocaine hydrochloride monohydrate, registered in Ireland by Laboratoires Thea. The same ATC class is registered in 10 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Tropicamid, kombinationen is registered in 10 of 19 countries.
Countries holding a registration under ATC S01FA56 (tropicamid, kombinationen), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Tropicamid, kombinationen · ATC S01FA56
10 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Tropicamide + Phenylephrine hydrochloride + Lidocaine Hydrochloride Monohydrate
- Manufacturer
- Laboratoires Thea
- Country
- Ireland (IE)
- ATC code
- S01FA56
- ATC class
- Tropicamid, Kombinationen
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA1107/012/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tropicamid, kombinationen in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaMYDRANELaboratoires Thea, Clermont-Ferrand
- SwitzerlandMydrane, solution injectableTHEA Pharma S.A.
- NetherlandsMydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml oplossing voor injectieLaboratoires Théa
- NorwayMydaneLaboratoires Thea S.A.S
- FranceMYDRANE 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml, solution injectableTHEA
- IcelandMYDRANELaboratoires THEA*
- PolandMydraneLaboratoires THEA
- SwedenMydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml Injektionsvätska, lösningLaboratoires THEA
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Mydrane
- Belgium · Mydrane
- Bulgaria · Мидран
- Cyprus · Mydrane
- Czechia · Mydrane
- Germany · Mydrane
- Denmark · Mydrane
- Spain · Fydrane
- Finland · Mydrane
- France · Mydrane
- United Kingdom (Northern Ireland) · Mydrane
- Greece · Mydrane
- Croatia · Mydrane
- Iceland · Mydrane
- Italy · Mydrane
- Luxembourg · Mydrane
- Netherlands · Mydrane
- Norway · Mydane
- Poland · Mydrane
- Portugal · Mydrane
- Romania · Mydrane
- Sweden · Mydrane
- Slovenia · Mydrane
- Slovakia · Mydrane
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/64bbc08d-9e7f-42f5-b4f4-29d9d76d0d61 GET /v1/drugs/64bbc08d-9e7f-42f5-b4f4-29d9d76d0d61?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": "Solution for injection",
"routes": [
"Intraocular use"
],
"source": "hpra",
"atc_all": [
"S01FA",
"S01FA56"
],
"strength": null,
"pa_number": "PA1107/012/001",
"substances": [
"Tropicamide",
"Phenylephrine hydrochloride",
"Lidocaine Hydrochloride Monohydrate"
],
"legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "28/08/2015",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about tropicamid, kombinationen.
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.