Drug Database
Back to search

Ireland· IE-PA-PPA23080/021/002

Symbicort Turbohaler 400 micrograms/12 micrograms/inhalation, inhalation powder

A formoterol and budesonide product containing budesonide dihydrate + formoterol fumarate dihydrate, registered in Ireland by Merit Pharmaceuticals Limited. The same ATC class is registered in 14 of our 19 countries.

ATC R03AK07

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSymbicort Turbohaler 400 micrograms/1…ATCR03AK07REGISTER NO.IE-PA-PPA23080/021/002PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about budesonide dihydrate + formoterol fumarate dihydrateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Formoterol and budesonide is registered in 14 of 19 countries.

Countries holding a registration under ATC R03AK07 (formoterol and budesonide), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 9 of them publish a price we can compare per daily dose
Search formoterol and budesonide products by name

Formoterol and budesonide · ATC R03AK07

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Budesonide dihydrate + Formoterol fumarate dihydrate
Manufacturer
Merit Pharmaceuticals Limited
Country
Ireland (IE)
ATC code
R03AK07
ATC class
Formoterol and budesonide
Defined daily dose
24 mcg, Inhal
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PPA23080/021/002

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Formoterol and budesonide in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All formoterol and budesonide products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Symbicort, Symbicort Forte Turbohaler
  • Belgium · Airbufo Forspiro, Bufomix Easyhaler
  • Bulgaria · Airbufo® Forspiro®, Буфомикс Изихалер
  • Cyprus · Bufar Easyhaler, Pulmoton
  • Czechia · Airbufo Forspiro, Budesonidefformoterol Cipla
  • Germany · Airbufo Forspiro, Bufori Easyhaler
  • Denmark · Budesonid/Formoterolfumaratdihydrat Cipla, Bufomix Easyhaler
  • Estonia · Airbufo Forspiro, Bufomix Easyhaler
  • Spain · Budesonida/Formoterol Cipla, Bufomix Easyhaler
  • Finland · Bufomix Easyhaler, Symbicort
  • France · Budesonide/Formoterol Forspiro Sandoz, Gibiter Easyhaler
  • United Kingdom (Northern Ireland) · Duoresp Spiromax, Fobumix Easyhaler
  • Greece · Pulmoresp, Pulmoton
  • Croatia · Airbufo Forspiro, Symbicort
  • Hungary · Bufomix Easyhaler, Pulmalio
  • Iceland · Biresp Spiromax, Bufomix Easyhaler
  • Italy · Budesonide E Formoterolo Cipla, Budesonide Formoterolo
  • Liechtenstein · Biresp Spiromax, Duoresp Spiromax
  • Lithuania · Bufomix Easyhaler, Symbicort
  • Luxembourg · Bufomix Easyhaler, Symbicort
  • Latvia · Airbufo Forspiro, Bufomix Easyhaler
  • Malta · Airbufo Forspiro, Symbicort
  • Netherlands · Airbufo Forspiro, Budesonide/Formoterolfumaraatdihydraat Cipla
  • Norway · Airbufo Forspiro, Biresp Spiromax
  • Poland · Airbufo Forspiro, Budesonide + Formoterol Cipla
  • Portugal · Assieme Turbohaler, Assieme Turbohaler 320/9
  • Romania · Airbufo Forspiro, Symbicort
  • Sweden · Airbufo Forspiro, Budesonide/Formoterol Cipla
  • Slovenia · Airbufo Forspiro, Bufomix Easyhaler
  • Slovakia · Bufomix Easyhaler, Symbicort

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/bdcfa80e-a649-4433-843d-d9a47941f13f
GET /v1/drugs/bdcfa80e-a649-4433-843d-d9a47941f13f?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": "Inhalation powder",
  "routes": [
    "Inhalation use"
  ],
  "source": "hpra",
  "atc_all": [
    "R03AK07"
  ],
  "strength": null,
  "pa_number": "PPA23080/021/002",
  "substances": [
    "Budesonide dihydrate",
    "Formoterol fumarate dihydrate"
  ],
  "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC",
  "market_info": "Unknown",
  "authorised_at": "25/08/2020",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

See everything about formoterol and budesonide.

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.

Try it freeOpen in the console