Netherlands· NL-01c713657cab
Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml oplossing voor injectie
A tropicamid, kombinationen product containing fenylefrinehydrochloride + lidocainehydrochloride 1-water + tropicamide, registered in Netherlands by BModesto B.V.. The same ATC class is registered in 10 of our 19 countries.
Checked against CBG-MEB (Netherlands) 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: Netherlands, from CBG-MEB (Netherlands)
- 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
CBG-MEB (Netherlands)- Active substance
- FENYLEFRINEHYDROCHLORIDE + LIDOCAINEHYDROCHLORIDE 1-WATER + TROPICAMIDE
- Manufacturer
- BModesto B.V.
- Country
- Netherlands (NL)
- ATC code
- S01FA56
- ATC class
- Tropicamid, Kombinationen
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_id136928//115295
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.
- 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
- 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
- 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 CBG-MEB (Netherlands). 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/6ae67f96-6c61-439d-906d-a748b2887b1d GET /v1/drugs/6ae67f96-6c61-439d-906d-a748b2887b1d?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": "Oplossing voor injectie",
"route": "Intraoculair gebruik",
"soort": "RVG",
"source": "cbg_meb",
"smpc_url": "https://www.geneesmiddeleninformatiebank.nl/smpc/h115295_smpc.pdf",
"strength": null,
"atc_label": "Tropicamide, Combinations",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/rvg136928",
"excipients": [
"DINATRIUMEDETAAT 2-WATER",
"DINATRIUMWATERSTOFFOSFAAT 12-WATER (E 339)",
"DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339)",
"NATRIUMCHLORIDE",
"WATER VOOR INJECTIE"
],
"substances": [
"FENYLEFRINEHYDROCHLORIDE",
"LIDOCAINEHYDROCHLORIDE 1-WATER",
"TROPICAMIDE"
],
"leaflet_url": "https://www.geneesmiddeleninformatiebank.nl/bijsluiters/h136928.pdf",
"authorised_at": "2026/07/09",
"procedure_number": null,
"dispensing_status": "Uitsluitend recept",
"registration_number": "136928//115295",
"additional_monitoring": "N"
}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.