Poland· PL-100348881
Mydrane
A tropicamid, kombinationen product containing tropicamidum + phenylephrini hydrochloridum + lidocaini hydrochloridum monohydricum, registered in Poland by Laboratoires THEA. The same ATC class is registered in 10 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Tropicamidum + Phenylephrini hydrochloridum + Lidocaini hydrochloridum monohydricum
- Manufacturer
- Laboratoires THEA
- Country
- Poland (PL)
- ATC code
- S01FA56
- ATC class
- Tropicamid, Kombinationen
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 5
- gtin05909991254667
- gtin05909991254674
- gtin03400955055501
- gtin03662042003394
- gtin05909991254681
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
- IrelandFydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injectionLaboratoires Thea
- IcelandMYDRANELaboratoires 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
- Ireland · Fydrane
- Iceland · Mydrane
- Italy · Mydrane
- Luxembourg · Mydrane
- Netherlands · Mydrane
- Norway · Mydane
- 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 URPL (Poland). 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/55bd29fa-e59c-4312-bffa-4ca5dfc18a6f GET /v1/drugs/55bd29fa-e59c-4312-bffa-4ca5dfc18a6f?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": "Roztwór do wstrzykiwań",
"source": "urpl",
"strength": "(0,2 mg + 3,1 mg + 10 mg)/ml",
"packaging": "05909991254667 ¦ Rpz ¦ Skasowane ¦ 113291\n1 amp. 0,6 ml\n05909991254674 ¦ Rpz ¦ 113292\n20 amp. 0,6 ml\n¦ UR/Z/4c/041/23 - 03400955055501 ¦ UR/Z/4c/230/25 - 03662042003394\n05909991254681 ¦ Rpz ¦ 113293\n100 amp. 0,6 ml",
"substance": "Tropicamidum 0.2 mg/ml + Phenylephrini hydrochloridum 3.1 mg/ml + Lidocaini hydrochloridum monohydricum 10 mg/ml",
"common_name": "Tropicamidum + Phenylephrini hydrochloridum + Lidocaini hydrochloridum monohydricum",
"pl_product_id": "100348881",
"pozwolenie_nr": "22899",
"auth_procedure": "DCP",
"authorisation_validity": "Bezterminowe"
}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.