Germany· DE-A57-051bf9b2f246f621
Isopto-Max
A medicinal product containing neomycin sulfate, polymyxin b sulfate, dexamethasone, 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
- Neomycin Sulfate, Polymyxin B Sulfate, Dexamethasone
- 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
Neomycin sulfate, polymyxin b sulfate, dexamethasone in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesMaxitrolHarrow Eye, LLC
- CzechiaMAXITROLNovartis s.r.o., Praha
- FinlandMaxitrolNovartis Finland Oy
- IrelandMaxitrol 0.1% w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspensionNovartis Ireland Limited
- NorwayMaxitrolNOVARTIS NORGE AS
Authorised across Europe · EMA
The same active substance is authorised in 18 EEA countries. Names it is sold under:
- Belgium · Maxitrol
- Bulgaria · Макситрол, Неладекс
- Cyprus · Isopto Maxitrol
- Czechia · Maxitrol
- Estonia · Maxitrol
- Spain · Maxitrol
- France · Maxidrol
- United Kingdom (Northern Ireland) · Maxitrol
- Croatia · Maxitrol
- Ireland · Maxitrol
- Iceland · Maxitrol
- Lithuania · Maxitrol
- Luxembourg · Maxitrol
- Latvia · Maxitrol
- Norway · Maxitrol
- Poland · Maxitrol
- Romania · Maxitrol
- Slovenia · Maxitrol
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/443e78b8-1673-4dd7-93e7-604f4c147a10 GET /v1/drugs/443e78b8-1673-4dd7-93e7-604f4c147a10?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": "Neomycin Sulfate, Polymyxin B Sulfate, Dexamethasone",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about neomycin sulfate, polymyxin b sulfate, dexamethasone.
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.