Spain· ES:80177
FYDRANE 0,2 MG/ML + 3,1 MG/ML + 10 MG/ML SOLUCION INYECTABLE
A medicinal product containing tropicamida + fenilefrina + lidocaína, registered in Spain by Laboratoires Thea.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- tropicamida + fenilefrina + lidocaína
- Manufacturer
- Laboratoires Thea
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Tropicamida + fenilefrina + lidocaína 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 injectieBModesto B.V.
- NorwayMydaneLaboratoires Thea S.A.S
- 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
- Czechia · Mydrane
- Germany · Mydrane
- Denmark · Mydrane
- 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 AEMPS CIMA (Spain). 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/135de3d5-bce5-4b41-9ab5-759d490c5fa4 GET /v1/drugs/135de3d5-bce5-4b41-9ab5-759d490c5fa4?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1452553200000}",
"nregistro": "80177",
"substance": "tropicamida + fenilefrina + lidocaína"
}See everything about tropicamida + fenilefrina + lidocaína.
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.