Ireland· IE-PA-PA0711/324/001
Azelastine hydrochloride /Fluticasone propionate Rowex 137 micrograms/50 micrograms per actuation, nasal spray suspension
A fluticason, kombinationen product containing azelastine hydrochloride + fluticasone propionate, registered in Ireland by Rowex Limited,. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) 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: Ireland, from HPRA (Ireland)
- 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
HPRA (Ireland)- Active substance
- Azelastine hydrochloride + Fluticasone propionate
- Manufacturer
- Rowex Limited,
- Country
- Ireland (IE)
- ATC code
- R01AD58
- ATC class
- Fluticason, Kombinationen
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA0711/324/001
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
- PolandAllerduoSTADA 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.
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
- 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
- Poland · Allerduo, Azaneson
- 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 HPRA (Ireland). 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/b8c2b184-d1c8-46b2-a9a4-da911d75f277 GET /v1/drugs/b8c2b184-d1c8-46b2-a9a4-da911d75f277?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": "Nasal spray, suspension",
"routes": [
"Nasal use"
],
"source": "hpra",
"atc_all": [
"R01AD58"
],
"strength": null,
"pa_number": "PA0711/324/001",
"substances": [
"Azelastine hydrochloride",
"Fluticasone propionate"
],
"legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "27/10/2023",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": "IC0166-204-070"
}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.