Czechia· CZ-0206480
MYDRANE
A tropicamid, kombinationen product containing tropicamide + phenylephrine hydrochloride + lidocaine hydrochloride monohydrate, registered in Czechia by Laboratoires Thea, Clermont-Ferrand. The same ATC class is registered in 10 of our 19 countries.
Checked against SÚKL (Czech Republic) 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: Czechia, from SÚKL (Czech Republic)
- 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
SÚKL (Czech Republic)- Active substance
- TROPICAMIDE + PHENYLEPHRINE HYDROCHLORIDE + LIDOCAINE HYDROCHLORIDE MONOHYDRATE
- Manufacturer
- Laboratoires Thea, Clermont-Ferrand
- Country
- Czechia (CZ)
- ATC code
- S01FA56
- ATC class
- Tropicamid, Kombinationen
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- 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
- IrelandFydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injectionLaboratoires Thea
- 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
- Germany · Mydrane
- Denmark · Mydrane
- Spain · Fydrane
- Finland · Mydrane
- France · Mydrane
- United Kingdom (Northern Ireland) · Mydrane
- Greece · Mydrane
- Croatia · Mydrane
- Ireland · Fydrane
- 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 SÚKL (Czech Republic). 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/aab5e325-0572-4a11-bd75-16d33c06bd1d GET /v1/drugs/aab5e325-0572-4a11-bd75-16d33c06bd1d?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": "INJ SOL",
"source": "sukl",
"strength": null,
"pack_size": "100X0,6ML+100J",
"substance": "TROPICAMIDE + PHENYLEPHRINE HYDROCHLORIDE + LIDOCAINE HYDROCHLORIDE MONOHYDRATE",
"cz_kod_sukl": "0206480",
"product_type": "CH",
"substance_codes": "1757,1122,831",
"registration_state": "R",
"registration_number": "64/399/15-C"
}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.