Czechia· CZ-0185499
BIRESP SPIROMAX
A formoterol and budesonide product containing budesonide + formoterol fumarate dihydrate, registered in Czechia by Teva Pharma B.V., Haarlem. The same ATC class is registered in 14 of our 19 countries.
Checked against SÚKL (Czech Republic) on
Informational only — not a medical device.
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: Czechia, from SÚKL (Czech Republic)
- 9 of them publish a price we can compare per daily dose
Formoterol and budesonide · ATC R03AK07
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
SÚKL (Czech Republic)- Active substance
- BUDESONIDE + FORMOTEROL FUMARATE DIHYDRATE
- Manufacturer
- Teva Pharma B.V., Haarlem
- Country
- Czechia (CZ)
- ATC code
- R03AK07
- ATC class
- Formoterol and budesonide
- Defined daily dose
- 24 mcg, Inhal
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 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
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.
- PolandGoResp DigihalerTeva Pharma B.V.
- SwedenAirbufo Forspiro 160 mikrogram/4,5 mikrogram/inhalation Inhalationspulver, avdelad dosSandoz A/S
- United KingdomDuoResp Spiromax 160micrograms/dose / 4.5micrograms/dose dry powder inhalerPharmaram Ltd
- FinlandAerocomp ForspiroSandoz A/S
- NetherlandsAirBuFo Forspiro 160/4,5 microgram/dosis, inhalatiepoeder, voorverdeeldSandoz B.V.
- SpainBiResp Spiromax 160 microgramos / 4,5 microgramos polvo para inhalacionTeva Pharma B.V.
- United StatesBREYNAMylan Pharmaceuticals Inc.
- IrelandAirBuFo Forspiro 160 microgram/4.5 microgram/dose inhalation powder, pre-dispensedRowex Limited,
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
- 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
- Ireland · Airbufo Forspiro, Bufomix Easyhaler
- 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 SÚKL (Czech Republic). 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/d8b2746f-7ce8-4147-b2a3-ff0b758db827 GET /v1/drugs/d8b2746f-7ce8-4147-b2a3-ff0b758db827?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": "INH PLV",
"source": "sukl",
"strength": "320MCG/9MCG",
"pack_size": "2X60DÁV",
"substance": "BUDESONIDE + FORMOTEROL FUMARATE DIHYDRATE",
"cz_kod_sukl": "0185499",
"product_type": "CH",
"substance_codes": "5362,14188",
"registration_state": "R",
"registration_number": "EU/1/14/921/005"
}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.