Ireland· IE-PA-EU/1/21/1604/001-002
Riltrava Aerosphere 5/7.2/160 micrograms pressurised inhalation, suspension
A formoterol, glycopyrronium bromid und budesonid product containing formoterol fumarate dihydrate + glycopyrronium bromide + budesonide, registered in Ireland by AstraZeneca AB. 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
Formoterol, glycopyrronium bromid und budesonid is registered in 11 of 19 countries.
Countries holding a registration under ATC R03AL11 (formoterol, glycopyrronium bromid und budesonid), 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
Formoterol, glycopyrronium bromid und budesonid · ATC R03AL11
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Formoterol fumarate dihydrate + Glycopyrronium bromide + Budesonide
- Manufacturer
- AstraZeneca AB
- Country
- Ireland (IE)
- ATC code
- R03AL11
- ATC class
- Formoterol, Glycopyrronium bromid und Budesonid
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/21/1604/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Formoterol, glycopyrronium bromid und budesonid in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaTRIXEO AEROSPHEREAstraZeneca AB, Södertälje
- FinlandRiltrava AerosphereAstraZeneca AB
- SwedenRiltrava Aerosphere 5 mikrogram/7,2 mikrogram/160 mikrogram Inhalationsspray, suspensionAstraZeneca AB
- United StatesBREZTRIAstraZeneca Pharmaceuticals LP
- United KingdomTrixeo Aerosphere 5micrograms/dose / 7.2micrograms/dose / 160micrograms/dose pressurised inhalerAstraZeneca UK Ltd
- NorwayTrixeo AerosphereAstraZeneca AB (2)
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Riltrava Aerosphere, Trixeo Aerosphere
- Liechtenstein · Riltrava Aerosphere, Trixeo Aerosphere
- Norway · Riltrava Aerosphere, Trixeo Aerosphere
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/5c16cdf6-4917-4696-8a8c-ba096cbd0c1e GET /v1/drugs/5c16cdf6-4917-4696-8a8c-ba096cbd0c1e?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": "Pressurised inhalation, suspension",
"routes": [
"Inhalation use"
],
"source": "hpra",
"atc_all": [
"R03AL11"
],
"strength": null,
"pa_number": "EU/1/21/1604/001-002",
"substances": [
"Formoterol fumarate dihydrate",
"Glycopyrronium bromide",
"Budesonide"
],
"legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "06/01/2022",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about formoterol, glycopyrronium bromid und budesonid.
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.