Germany· DE-A57-1eda36859eff8ac9
Pulmelia
A medicinal product containing budesonide, formoterol fumarate dihydrate ph.eur., registered in Germany by Elpen Pharmaceutical Co. Inc..
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
- Budesonide, Formoterol Fumarate Dihydrate Ph.Eur.
- Manufacturer
- Elpen Pharmaceutical Co. Inc.
- 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
Budesonide, formoterol fumarate dihydrate ph.eur. in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenAirbufo Forspiro 160 mikrogram/4,5 mikrogram/inhalation Inhalationspulver, avdelad dosSandoz A/S
- CzechiaAIRBUFO FORSPIROSandoz s.r.o., Praha
- United KingdomDuoResp Spiromax 160micrograms/dose / 4.5micrograms/dose dry powder inhalerDE Pharmaceuticals
- 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.
- PolandAirbufo ForspiroSandoz GmbH
- United StatesBREYNAMylan Pharmaceuticals Inc.
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
- 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 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/c3bbe1dd-57a8-4d49-a19a-fe8eaf97a0d5 GET /v1/drugs/c3bbe1dd-57a8-4d49-a19a-fe8eaf97a0d5?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": "Inhalation Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Budesonide, Formoterol Fumarate Dihydrate Ph.Eur.",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about budesonide, formoterol fumarate dihydrate ph.eur..
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.