Sweden· SE-20010323000131
Gardette mite 80 mikrogram/4,5 mikrogram/inhalation Inhalationspulver
A medicinal product containing budesonide + formoterol fumarate dihydrate, registered in Sweden by AstraZeneca AB.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Budesonide + Formoterol Fumarate Dihydrate
- Manufacturer
- AstraZeneca AB
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20010323000131
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Budesonide + formoterol fumarate dihydrate in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAIRBUFO FORSPIROSandoz s.r.o., Praha
- United KingdomDuoResp Spiromax 160micrograms/dose / 4.5micrograms/dose dry powder inhalerTeva UK 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.
- PolandAirbufo ForspiroSandoz GmbH
- 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
- 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
- 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
- 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 Swedish Medical Products Agency (Sweden). 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/afab4bf0-4936-44ac-b6c6-c086e3a6f8ec GET /v1/drugs/afab4bf0-4936-44ac-b6c6-c086e3a6f8ec?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.
{
"source": "lakemedelsverket",
"doc_types": [
"SmPC",
"PL"
],
"se_npl_id": "20010323000131",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20010323000131",
"product_doc_link": "https://docetp.mpa.se/LMF/Gardette%20mite%20inhalation%20powder%20ENG%20SmPC_09001bee807a34a0.pdf"
}See everything about budesonide + formoterol fumarate dihydrate.
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.