Spain· ES:63198
MIFLONIDE BREEZHALER 400 MICROGRAMOS POLVO PARA INHALACION (CAPSULA DURA)
A medicinal product containing budesonida, registered in Spain by Novartis Farmaceutica S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- budesonida
- Manufacturer
- Novartis Farmaceutica S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo88828960EUR 14.71
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Budesonida in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomBudesonide 400 CyclocapsTeva UK Ltd
- FinlandBudesonid EasyhalerOrion Corporation
- CzechiaGIONA EASYHALEROrion Corporation, Espoo
- NetherlandsBudesonide 400 Cyclocaps, inhalatiepoeder in harde capsule 400 microgramTeva B.V.
- PolandBudesonide EasyhalerOrion Corporation
- ItalyBUDESONIDE VIATRISVIATRIS HEALTHCARE LIMITED
- BelgiumBudesonide Easyhaler 400 µgOrion
- IrelandPulmicort Turbohaler 400 micrograms Inhalation PowderAstraZeneca AB
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Budenofalk, Budo-San
- Belgium · Budenofalk, Budesonid Sandoz
- Bulgaria · Airbudenid, Буденофалк
- Cyprus · Axelovert, Biosonide
- Czechia · Budenofalk, Budenofalk Uno
- Germany · Aquacort, Budapp Nasal
- Denmark · Benarhin, Budenofalk
- Estonia · Budesonid Sandoz, Budesonide
- Finland · Budenofalk, Budesonid Easyhaler Orion
- France · Budésonide Arrow, Budesonide Biogaran
- United Kingdom (Northern Ireland) · Benacort, Benacort Hayfever Relief For Adults
- Greece · Aurid, Axelovert
- Croatia · Budelin Novolizer, Budosan
- Hungary · Budenofalk, Budesonid Easyhaler
- Ireland · Budenofalk, Budesonide Azure
- Iceland · Budesonide Stada, Cortiment
- Italy · Aircort, Bidien
- Liechtenstein · Jorveza, Kinpeygo
- Lithuania · Budenofalk, Budesonide Ferring
- Luxembourg · Budenofalk, Budesonide Eg
- Latvia · Budenofalk, Budesonid Sandoz
- Malta · Budesonida Aldo-Unión, Budesonide Azure
- Netherlands · Budenofalk, Budenofalk Schuim
- Norway · Budenofalk, Budesonid Medical Valley
- Poland · Bds N, Benodil
- Portugal · Aeromax, Budenofalk
- Romania · Budenofalk, Budenofalk Uno
- Sweden · Budaxiro, Budenofalk
- Slovenia · Budenofalk, Budesonid Easyhaler Orion
- Slovakia · Budelin Novolizer, Budenofalk
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 AEMPS CIMA (Spain). 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/fafe0bd9-22ec-4c39-8796-7f765600e6f8 GET /v1/drugs/fafe0bd9-22ec-4c39-8796-7f765600e6f8?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración",
"estado": "{\"aut\":962316000000,\"susp\":1743666910000}",
"nregistro": "63198",
"substance": "budesonida"
}See everything about budesonida.
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.