Germany· DE-A57-3d5d3122ab865908
Mydriasert
A medicinal product containing phenylephrine hydrochloride, tropicamide, registered in Germany by Laboratoires Thea.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Phenylephrine Hydrochloride, Tropicamide
- Manufacturer
- Laboratoires Thea
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Phenylephrine hydrochloride, tropicamide 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 mgEuro Registratie Collectief B.V.
- SwitzerlandMydriasert, insert ophtalmiqueTHEA Pharma S.A.
- 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
- SpainMYDRIASERT 0,28 mg/5,4 mg INSERTO OFTALMICOLaboratoires Thea
Authorised across Europe · EMA
The same active substance is authorised in 12 EEA countries. Names it is sold under:
- Austria · Mydriasert
- Belgium · Mydriasert
- Denmark · Mydriasert
- Spain · Mydriasert
- Finland · Mydriasert
- France · 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 EMA Article 57 (European Union). 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/3f4a634a-c93d-4c09-ae0a-b6869d975e62 GET /v1/drugs/3f4a634a-c93d-4c09-ae0a-b6869d975e62?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.
{
"pzn": null,
"route": "Ocular Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Phenylephrine Hydrochloride, Tropicamide",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about phenylephrine hydrochloride, tropicamide.
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.