Poland· PL-100482281
Libara
A fluticason, kombinationen product containing azelastini hydrochloridum + fluticasoni propionas, registered in Poland by Berlin-Chemie AG. The same ATC class is registered in 11 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Fluticason, kombinationen is registered in 11 of 19 countries.
Countries holding a registration under ATC R01AD58 (fluticason, kombinationen), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 7 of them publish a price we can compare per daily dose
Fluticason, kombinationen · ATC R01AD58
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
URPL (Poland)- Active substance
- Azelastini hydrochloridum + Fluticasoni propionas
- Manufacturer
- Berlin-Chemie AG
- Country
- Poland (PL)
- ATC code
- R01AD58
- ATC class
- Fluticason, Kombinationen
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin05909991554798
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fluticason, kombinationen in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- GermanyAllergo-DuolindDoppelherz Pharma Gmbh
- SwedenAzeflone 125 mikrogram + 50 mikrogram/sprayning Nässpray, suspensionSTADA Arzneimittel AG
- CzechiaAZELASTIN/FLUTIKASON TEVATeva B.V., Haarlem
- United KingdomDymista 137micrograms/dose / 50micrograms/dose nasal sprayPilsco Ltd
- FinlandAllestinOrifarm Healthcare A/S
- NetherlandsAzelastine/Fluticasonpropionaat ACE 137 microgram/50 microgram per verstuiving neusspray, suspensieACE Pharmaceuticals B.V.
- SpainARESPINDUO 137 MICROGRAMOS/50 MICROGRAMOS/PULSACION SUSPENSION PARA PULVERIZACION NASALAflofarm Farmacja Polska Sp. Z O.O.
- United StatesAzelastine hydrochloride and Fluticasone propionateApotex Corp.
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Azelastin/Fluticason Orifarm, Azelastin/Fluticason Ratiopharm
- Bulgaria · Azelastine/Fluticasone Pharmascience, Димиста
- Cyprus · Azemista, Bileni
- Czechia · Azelastin/Flutikason Teva, Dymistin
- Germany · Allergo-Duolind, Azeflunal
- Denmark · Azecort, Azeflone
- Estonia · Azelastine/Fluticasone Teva, Azelastine/Fluticasone Zentiva
- Spain · Arespinduo, Avancort Duo
- Finland · Acirasi, Allestin
- France · Azaflunex, Azelastine Chlorhydrate / Fluticasone Propionate Biogaran
- United Kingdom (Northern Ireland) · Adsego, Allenasal Duo
- Greece · Azelastine+fluticasone Win Medica, Azemista
- Croatia · Dymista, Fogilix
- Hungary · Azelastine/Fluticasone Stada, Azelasztin/Flutikazon
- Ireland · Azecort, Azelastine Hydrochloride/Fluticasone Propionate Rowex
- Iceland · Azecort, Duonasa Nefúði
- Italy · Azefluxin, Azelastina E Fluticasone
- Lithuania · Azavin, Azecort
- Luxembourg · Dymista, Dymista Nasenspray
- Latvia · Azecort, Azelastine/Fluticasone Teva
- Malta · Azecort, Dymista
- Netherlands · Azelastine Hydrochloride & Fluticasone Propionate Viatris Healthcare, Azelastine/Fluticasonpropionaat
- Norway · Altimista, Azeflone
- Portugal · Azecort, Azelastina + Fluticasona
- Romania · Dymista, Lutonaze
- Sweden · Azeflone Stada, Azelastin/Flutikason Teva
- Slovenia · Dymista, Dymol
- Slovakia · Azecort, Azelastín/Flutikazón Stada
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/c8b74442-48ee-4bb2-8333-f219b395ebae GET /v1/drugs/c8b74442-48ee-4bb2-8333-f219b395ebae?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": "Aerozol do nosa, zawiesina",
"source": "urpl",
"strength": "(137 mcg + 50 mcg)/dawkę donosową",
"packaging": "05909991554798 ¦ Rp ¦ 158088\n1 butelka 120 dawek (23 g)",
"substance": "Azelastini hydrochloridum 0.137 mg/dawkę + Fluticasoni propionas 0.05 mg/dawkę",
"common_name": "Azelastini hydrochloridum + Fluticasoni propionas",
"pl_product_id": "100482281",
"pozwolenie_nr": "28605",
"auth_procedure": "DCP",
"authorisation_validity": "2029-09-19"
}See everything about fluticason, kombinationen.
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.