Poland· PL-100428717
Cetraxal Plus
A fluocinolon acetonid und antiinfektiva product containing ciprofloxacinum + fluocinoloni acetonidum, registered in Poland by PharmaVitae Sp. z o.o. sp. k.. The same ATC class is registered in 7 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Fluocinolon acetonid und antiinfektiva is registered in 7 of 19 countries.
Countries holding a registration under ATC S02CA05 (fluocinolon acetonid und antiinfektiva), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 5 of them publish a price we can compare per daily dose
Fluocinolon acetonid und antiinfektiva · ATC S02CA05
7 / 19 countries
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Norwayprice
- Polandprice
The record
At a glance
URPL (Poland)- Active substance
- Ciprofloxacinum + Fluocinoloni acetonidum
- Manufacturer
- PharmaVitae Sp. z o.o. sp. k.
- Country
- Poland (PL)
- ATC code
- S02CA05
- ATC class
- Fluocinolon acetonid und Antiinfektiva
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin05909991419639
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fluocinolon acetonid und antiinfektiva in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandCetraxal CompParanova Oy
- GermanyInfectociprocortPädia Gmbh, De, Heppenheim
- IcelandCetraxal CompPOA Pharma Scandinavia AB
- CzechiaINFALIN DUOLaboratorios Salvat, S.A., Esplugues de Llobregat
- CanadaOTIXALMEDEXUS PHARMACEUTICALS INC.
- United KingdomCetraxal Plus 3mg/ml + 0.25mg/ml ear drops 0.25ml unit doseAspire Pharma Ltd
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Austria · Infectociprocort
- Czechia · Infalin Duo
- Germany · Infectociprocort
- Denmark · Cetraxal Comp, Cetraxal Comp Ukonserveret
- Estonia · Bonadix
- Spain · Aceoto Plus, Cetraxal Plus
- Finland · Cetraxal Comp
- France · Cetraxal
- United Kingdom (Northern Ireland) · Cetraxal Plus
- Greece · Otospon
- Croatia · Ciprofloksacin/Flucinolonacetonid Goodwill
- Hungary · Duoxal
- Iceland · Cetraxal Comp
- Italy · Cexidal
- Lithuania · Bonadix
- Latvia · Bonadix
- Malta · Cetraxal Plus
- Norway · Cetraxal Comp
- Portugal · Cetraxal Duo
- Romania · Cexidal, Ototis
- Sweden · Cetraxal Comp
- Slovakia · Infalin Duo
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 URPL (Poland). 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/0a482961-cf34-42c4-b1a1-c754d9704e57 GET /v1/drugs/0a482961-cf34-42c4-b1a1-c754d9704e57?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.
{
"form": "Krople do uszu, roztwór",
"source": "urpl",
"strength": "3 mg/ml + 0,25 mg/ml",
"packaging": "05909991419639 ¦ Rp ¦ 134806\n1 butelka 10 ml",
"substance": "Ciprofloxacinum 3 mg/ml + Fluocinoloni acetonidum 0.25 mg/ml",
"common_name": "Ciprofloxacinum + Fluocinoloni acetonidum",
"pl_product_id": "100428717",
"pozwolenie_nr": "431/19",
"auth_procedure": "IR",
"authorisation_validity": "2024-11-28"
}See everything about fluocinolon acetonid und antiinfektiva.
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.