Germany· DE-A57-e9b269fb64fe8d8c
Mydrane
A medicinal product containing lidocaine hydrochloride monohydrate, phenylephrine hydrochloride, tropicamide, registered in Germany by Laboratoires Thea.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Lidocaine Hydrochloride Monohydrate, Phenylephrine Hydrochloride, Tropicamide
- Manufacturer
- Laboratoires Thea
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
Lidocaine hydrochloride monohydrate, phenylephrine hydrochloride, tropicamide 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
- 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
- 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 EMA Article 57 (European Union). 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/c1733030-1cff-4719-abb4-3cfed2c9eebe GET /v1/drugs/c1733030-1cff-4719-abb4-3cfed2c9eebe?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.
{
"pzn": null,
"route": "Intracameral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Lidocaine Hydrochloride Monohydrate, Phenylephrine Hydrochloride, Tropicamide",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about lidocaine hydrochloride monohydrate, phenylephrine hydrochloride, tropicamide.
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.