Germany· DE-A57-074e3dac2481b232
Tobradex
A medicinal product containing dexamethasone, tobramycin, registered in Germany by Novartis Pharma Gmbh.
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
- Dexamethasone, Tobramycin
- Manufacturer
- Novartis Pharma Gmbh
- 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
Dexamethasone, tobramycin in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesTobraDexNovartis Pharmaceuticals Corporation
- PolandBrazoflaminSynoptis Pharma Sp. z o.o.
- United KingdomDexamethasone 0.1% / Tobramycin 0.3% eye dropsAlliance Healthcare (Distribution) Ltd
- NetherlandsBradexa 3 mg/ml + 1 mg/ml oogdruppels, suspensieRockmed Pharma B.V.
- FranceTOBRADEX, collyre en suspensionNOVARTIS PHARMA
- CanadaTOBRADEXNOVARTIS PHARMACEUTICALS CANADA INC
- SwitzerlandTobradex, AugensalbeNovartis Pharma Schweiz AG
- NorwayTobrasoneNOVARTIS NORGE AS
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Tobradex
- Belgium · Tobradex
- Bulgaria · Декс-Тобрин, Медетром
- Cyprus · Lofoto, Tobradex
- Czechia · Tobradex
- Denmark · Oridecin, Tobradex
- Estonia · Tobradex, Tobramycin/Dexamethasone Elvim
- Spain · Tobradex
- Finland · Tobrasone
- France · Tobradex, Todexal
- United Kingdom (Northern Ireland) · Tobradex, Tobramycin + Dexamethasone Blumont Pharma
- Greece · Lofoto, O-Biotic
- Croatia · Tobradex
- Hungary · Tobradex, Todep
- Iceland · Tobradex
- Italy · Iridina Infezioni E Infiammazioni, Luxabiotic
- Lithuania · Tobradex, Tobramycin/Dexamethasone Elvim
- Luxembourg · Tobradex
- Latvia · Tobradex, Tobramycin/Dexamethasone Elvim
- Malta · Tobradex
- Netherlands · Bradexa, Tobradex
- Norway · Tobrasone, Toflacort
- Poland · Brazoflamin, Mybracin
- Portugal · Dextob, Tobradex
- Romania · Dexatobrom, Tobradex
- Sweden · Tobrasone, Toflacort
- Slovenia · Tobradex
- Slovakia · Tobradex
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/de13839b-212d-4763-81ae-f59fc748108b GET /v1/drugs/de13839b-212d-4763-81ae-f59fc748108b?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": "Dexamethasone, Tobramycin",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dexamethasone, tobramycin.
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.