Germany· DE-A57-c660d81ee32e1871
Cilodex
A medicinal product containing dexamethasone, ciprofloxacin, registered in Germany by Pädia Gmbh, De, Heppenheim.
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, Ciprofloxacin
- Manufacturer
- Pädia Gmbh, De, Heppenheim
- 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, ciprofloxacin in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesCiprofloxacin and dexamethasoneARMAS PHARMACEUTICALS INC.
- United KingdomCilodex ear dropsConsilient Health Ltd
- CanadaCIPRODEXNOVARTIS PHARMACEUTICALS CANADA INC
- FranceCILOXADEX 3 mg/1 mg par mL, suspension pour instillation auriculaireINFECTOPHARM ARZNEIMITTEL UND CONSILIUM (ALLEMAGNE)
Authorised across Europe · EMA
The same active substance is authorised in 7 EEA countries. Names it is sold under:
- Cyprus · Ciprofloxacin/Dexamethasone Rafarm
- Denmark · Cilodex
- France · Ciloxadex, Sonixal
- United Kingdom (Northern Ireland) · Ciprofloxacin/Dexamethasone Aspire Pharma, Ciprofloxacin/Dexamethasone Infectopharm
- Greece · Ciprofloxacin+dexamethasone Rafarm
- Italy · Cilodex, Nisegal
- Portugal · Otifix
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/8135f0c7-d4df-4881-8935-6a462d4af92e GET /v1/drugs/8135f0c7-d4df-4881-8935-6a462d4af92e?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": "Auricular Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Dexamethasone, Ciprofloxacin",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dexamethasone, ciprofloxacin.
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.