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Netherlands· NL-8a22964ea4f8

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 Laboratoires Théa. The same ATC class is registered in 10 of our 19 countries.

ATC S01FA56

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedMydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg…ATCS01FA56REGISTER NO.NL-8a22964ea4f8PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about fenylefrinehydrochloride + lidocainehydrochloride 1-water + tropicamideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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
Search tropicamid, kombinationen products by name

Tropicamid, kombinationen · ATC S01FA56

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
FENYLEFRINEHYDROCHLORIDE + LIDOCAINEHYDROCHLORIDE 1-WATER + TROPICAMIDE
Manufacturer
Laboratoires Théa
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_id
    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.

All tropicamid, kombinationen products

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/c6bec998-cb4f-4246-8c0d-1fb0731bdb7f
GET /v1/drugs/c6bec998-cb4f-4246-8c0d-1fb0731bdb7f?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/rvg115295",
  "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/h115295.pdf",
  "authorised_at": "2016/02/15",
  "procedure_number": "DK/H/2439/001",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "115295",
  "additional_monitoring": "N"
}
API referenceMCP serverPlans

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.

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