Germany· DE-A57-d4ba12cca66ab36b
Azelastin/Fluticason Ace Pharmaceuticals
A medicinal product containing azelastine hydrochloride, fluticasone propionate, registered in Germany by Ace Pharmaceuticals Bv.
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
- Azelastine Hydrochloride, Fluticasone Propionate
- Manufacturer
- Ace Pharmaceuticals Bv
- 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
Azelastine hydrochloride, fluticasone propionate in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- 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.
- 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
- 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
- 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 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/c27af4ee-964e-414f-8d97-6f8664d3e395 GET /v1/drugs/c27af4ee-964e-414f-8d97-6f8664d3e395?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": "Nasal Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Azelastine Hydrochloride, Fluticasone Propionate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about azelastine hydrochloride, fluticasone propionate.
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.