France· FR:67423452
MYDRIASERT, insert ophtalmique
A medicinal product containing tropicamide + chlorhydrate de phényléphrine, 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
- 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 · 2
- cip1334009353728401 sachet(s) papier polyéthylène aluminium de 1 insert(s) avec pince stérile jetable
- cip13340093537290120 sachet(s) papier polyéthylène aluminium de 1 insert(s) avec pince stérile jetable
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tropicamide + chlorhydrate de phényléphrine in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsMydriasert, ooginsert 0,28 mg en 5,4 mgLaboratoires Théa
- SwitzerlandMydriasert, insert ophtalmiqueTHEA Pharma S.A.
- SpainMYDRIASERT 0,28 mg/5,4 mg INSERTO OFTALMICOLaboratoires Thea
- FinlandMydriasertLaboratoires Thea
- United KingdomMydriasert 5.4mg/0.28mg ophthalmic insertsThea Pharmaceuticals Ltd
- NorwayMydriasertLaboratoires Théa
- SwedenMydriasert 0,28 mg/5,4 mg ÖgonlamellLaboratoires THEA
- GermanyMydriasertLaboratoires 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
- United Kingdom (Northern Ireland) · Mydriasert
- Italy · Mydriasert, Visumidriatic Fenilefrina
- Luxembourg · Mydriasert
- Netherlands · 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 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/5f8648a6-61ed-4ea1-bb65-7c1ff44edd23 GET /v1/drugs/5f8648a6-61ed-4ea1-bb65-7c1ff44edd23?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": "67423452",
"date_amm": "2000-03-01",
"type_amm": "Procédure de reconnaissance mutuelle",
"numero_ue": null,
"substance": "TROPICAMIDE + CHLORHYDRATE DE PHÉNYLÉPHRINE",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "insert",
"voies_administration": "ophtalmique",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about tropicamide + chlorhydrate de phényléphrine.
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.