France· FR:65441590

GIBITER EASYHALER, 320 microgrammes/9 microgrammes/dose, poudre pour inhalation

A medicinal product containing budésonide + fumarate de formotérol dihydraté, registered in France by MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG, on the national reimbursement list.

Reimbursed in France (Assurance maladie)

Checked against Base de données publique des médicaments — BDPM (France) on September 12, 2026

Informational only — not a medical device.

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The record

At a glance

Base de données publique des médicaments — BDPM (France)

Active substance: BUDÉSONIDE + FUMARATE DE FORMOTÉROL DIHYDRATÉ
Manufacturer: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG
Country: France (FR)
ATC code: —
Reimbursed: Yes
Source register: Base de données publique des médicaments — BDPM (France)
Last checked: September 12, 2026

Packs & prices · 2

2 priced

cip13
3400930093245
1 inhalateur multidose (Easyhaler) en polyÃ©thylÃ¨ne basse densitÃ© (PEBD) polycarbonate styrÃ¨ne butadiÃ¨ne polypropylÃ¨ne polytÃ©rÃ©phthalate de butylÃ¨ne de 60 dose(s)
EUR 26.25
cip13
3400930221198
3 inhalateur(s) multidose(s) (Easyhaler) en polyÃ©thylÃ¨ne basse densitÃ© (PEBD) polycarbonate styrÃ¨ne butadiÃ¨ne polypropylÃ¨ne polytÃ©rÃ©phthalate de butylÃ¨ne de 60 dose(s)
EUR 77.95

Regulatory notes

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

Same medicine, other countries

Budésonide + fumarate de formotérol dihydraté in 15 other countries

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

All budésonide + fumarate de formotérol dihydraté 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
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 Base de données publique des médicaments — BDPM (France). 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/7c8bcec9-097a-4b77-93a8-dd7f494dae8a
GET /v1/drugs/7c8bcec9-097a-4b77-93a8-dd7f494dae8a?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.

{
  "cis": "65441590",
  "date_amm": "2017-09-20",
  "type_amm": "Procédure décentralisée",
  "numero_ue": null,
  "substance": "BUDÉSONIDE + FUMARATE DE FORMOTÉROL DIHYDRATÉ",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "poudre pour inhalation",
  "voies_administration": "inhalée",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}

API reference MCP server Plans

See everything about budésonide + fumarate de formotérol dihydraté.

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.

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