France· FR:65082408
MYDRANE 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml, solution injectable
A medicinal product containing tropicamide + chlorhydrate de phényléphrine + chlorhydrate de lidocaïne monohydraté, registered in France by THEA.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- TROPICAMIDE + CHLORHYDRATE DE PHÉNYLÉPHRINE + CHLORHYDRATE DE LIDOCAÏNE MONOHYDRATÉ
- Manufacturer
- THEA
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip13340095505550120 kits contenant 1 x 0,6 ml ampoule stérile et 1 aiguille-filtre de 5 µm stérile sous plaquette (papier/PVC)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tropicamide + chlorhydrate de phényléphrine + chlorhydrate de lidocaïne monohydraté 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
- Germany · Mydrane
- Denmark · Mydrane
- Spain · Fydrane
- Finland · 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 Base de données publique des médicaments — BDPM (France). 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/20921518-14b1-400d-9363-bae1a36e7404 GET /v1/drugs/20921518-14b1-400d-9363-bae1a36e7404?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.
{
"cis": "65082408",
"date_amm": "2016-02-08",
"type_amm": "Procédure décentralisée",
"numero_ue": null,
"substance": "TROPICAMIDE + CHLORHYDRATE DE PHÉNYLÉPHRINE + CHLORHYDRATE DE LIDOCAÏNE MONOHYDRATÉ",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "solution injectable",
"voies_administration": "intracamérulaire",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about tropicamide + chlorhydrate de phényléphrine + chlorhydrate de lidocaïne monohydraté.
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.