Poland· PL-100015984
Cortineff ophtalm. 0,1%
A medicinal product containing fludrocortisoni acetas, registered in Poland by Bausch+Lomb Ireland Ltd..
Checked against URPL (Poland) on
Informational only — not a medical device.
The record
At a glance
URPL (Poland)- Active substance
- Fludrocortisoni acetas
- Manufacturer
- Bausch+Lomb Ireland Ltd.
- Country
- Poland (PL)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin05909990104918
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fludrocortisoni acetas in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomFlorinef 100microgram tabletsMawdsley-Brooks & Company Ltd
- United Statesfludrocortisone acetateEywa Pharma Inc
- NetherlandsFlorinef Acetaat, tabletten 0,1 mgViatris Healthcare B.V.
- GermanyAstonin HMerck Healthcare Germany Gmbh
- FranceFLUCORTAC 100 microgrammes/mL, solution buvableHAC PHARMA
- SwedenCortiflix 0,1 mg TablettRenata Pharmaceuticals (Ireland) Limited
- SpainASTONIN 0,1 mg COMPRIMIDOSLaboratorios Ern S.A.
- IrelandFludrocortisone acetate 0.1 mg tabletsViatris Healthcare Limited
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Astonin H
- Bulgaria · Кортинеф
- Germany · Astonin H, Fludrocortison Accord
- Denmark · Cortiflix, Florinef
- Spain · Astonín, Fludrocortisona
- Finland · Cortiflix, Florinef
- France · Flucortac, Fludrocortisone Acetate Accord
- United Kingdom (Northern Ireland) · Fludrocortisone Acetate, Fludrocortisone Acetate Accord-Uk
- Greece · Felusil
- Croatia · Zonta
- Hungary · Astonin
- Ireland · Fludrocortisone Acetate Mylan, Fludrocortisone Acetate Renata
- Iceland · Florinef
- Lithuania · Cortineff
- Luxembourg · Astonin H
- Latvia · Cortineff, Fludrocortisone Acetate Renata
- Malta · Fludrocortisone Acetate Renata
- Netherlands · Florinef Acetaat, Fludrace
- Norway · Cortiflix, Florinef
- Portugal · Fludrocortisona Renata
- Romania · Astonin H
- Sweden · Cortiflix, Florinef
- Slovenia · Zonta
- Slovakia · Zonta
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/3d101c73-1f2b-4d56-8775-7bff90abadda GET /v1/drugs/3d101c73-1f2b-4d56-8775-7bff90abadda?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": "Maść do oczu",
"source": "urpl",
"strength": "1 mg/g",
"packaging": "05909990104918 ¦ Rp ¦ 2091\n1 tuba 3 g",
"substance": "Fludrocortisoni acetas 1 mg",
"common_name": "Fludrocortisoni acetas",
"pl_product_id": "100015984",
"pozwolenie_nr": "01049",
"auth_procedure": "NAR",
"authorisation_validity": "Bezterminowe"
}See everything about fludrocortisoni acetas.
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.