Spain· ES:76619
SYNAZE 137 MICROGRAMOS/50 MICROGRAMOS/APLICACION SUSPENSION PARA PULVERIZACION NASAL
A medicinal product containing fluticasona + azelastina, registered in Spain by Mylan Ire Healthcare Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- fluticasona + azelastina
- Manufacturer
- Mylan Ire Healthcare Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Fluticasona + azelastina 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 sprayNecessity Supplies Ltd
- FinlandAllestinOrifarm Healthcare A/S
- NetherlandsAzelastine/Fluticasonpropionaat ACE 137 microgram/50 microgram per verstuiving neusspray, suspensieACE Pharmaceuticals B.V.
- 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
- 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 AEMPS CIMA (Spain). 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/66f7883a-b82a-45f4-9946-063107b14a4e GET /v1/drugs/66f7883a-b82a-45f4-9946-063107b14a4e?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1366840800000,\"rev\":1651230990000}",
"nregistro": "76619",
"substance": "fluticasona + azelastina"
}See everything about fluticasona + azelastina.
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.