Netherlands· NL-1d9c32d67a0e
Mydriasert, ooginsert 0,28 mg en 5,4 mg
A tropicamid, kombinationen product containing fenylefrinehydrochloride + tropicamide, registered in Netherlands by Laboratoires Théa. 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 + 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_id33701
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tropicamid, kombinationen in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandMydriasert, insert ophtalmiqueTHEA Pharma S.A.
- GermanyMydriasertLaboratoires Thea
- SpainMYDRIASERT 0,28 mg/5,4 mg INSERTO OFTALMICOLaboratoires Thea
- FinlandMydriasertLaboratoires Thea
- FranceMYDRIASERT, insert ophtalmiqueTHEA
- United KingdomMydriasert 5.4mg/0.28mg ophthalmic insertsThea Pharmaceuticals Ltd
- NorwayMydriasertLaboratoires Théa
- SwedenMydriasert 0,28 mg/5,4 mg ÖgonlamellLaboratoires THEA
Authorised across Europe · EMA
The same active substance is authorised in 12 EEA countries. Names it is sold under:
- Austria · Mydriasert
- Belgium · Mydriasert
- Germany · Mydriasert
- Denmark · Mydriasert
- Spain · Mydriasert
- Finland · Mydriasert
- France · Mydriasert
- United Kingdom (Northern Ireland) · Mydriasert
- Italy · Mydriasert, Visumidriatic Fenilefrina
- Luxembourg · Mydriasert
- Portugal · Mydriasert
- Sweden · Mydriasert
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/f4013e42-c1a1-46d5-956b-3dee9c09adbc GET /v1/drugs/f4013e42-c1a1-46d5-956b-3dee9c09adbc?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": "Ooginsert",
"route": "Oculair gebruik",
"soort": "RVG",
"source": "cbg_meb",
"smpc_url": "https://www.geneesmiddeleninformatiebank.nl/smpc/h33701_smpc.pdf",
"strength": null,
"atc_label": "Tropicamide, Combinations",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/rvg33701",
"excipients": [
"AMMONIOMETHACRYLAATCOPOLYMEER TYPE A",
"COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) (E 1206)",
"ETHYLCELLULOSE (E 462)",
"GLYCEROLDIBEHENAAT"
],
"substances": [
"FENYLEFRINEHYDROCHLORIDE",
"TROPICAMIDE"
],
"leaflet_url": "https://www.geneesmiddeleninformatiebank.nl/bijsluiters/h33701.pdf",
"authorised_at": "2007/12/06",
"procedure_number": "FR/H/0273/001",
"dispensing_status": "Uitsluitend recept",
"registration_number": "33701",
"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.