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Czechia· CZ-0197360

BUFOMIX EASYHALER

A formoterol and budesonide product containing budesonide + formoterol fumarate dihydrate, registered in Czechia by Orion Corporation, Espoo. The same ATC class is registered in 14 of our 19 countries.

ATC R03AK07

Checked against SÚKL (Czech Republic) on

Informational only — not a medical device.

SOURCE REGISTER · CZSÚKL (Czech Republic)normalisedBUFOMIX EASYHALERATCR03AK07REGISTER NO.CZ-0197360PACKS LISTED0CHECKEDSeptember 28, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

SÚKL (Czech Republic)
Active substance
BUDESONIDE + FORMOTEROL FUMARATE DIHYDRATE
Manufacturer
Orion Corporation, Espoo
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.

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/cc124cb1-17c3-4b8e-ba94-51bf69556104
GET /v1/drugs/cc124cb1-17c3-4b8e-ba94-51bf69556104?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": "160MCG/4,5MCG",
  "pack_size": "1X60DÁV I",
  "substance": "BUDESONIDE + FORMOTEROL FUMARATE DIHYDRATE",
  "cz_kod_sukl": "0197360",
  "product_type": "CH",
  "substance_codes": "5362,14188",
  "registration_state": "R",
  "registration_number": "14/203/14-C"
}

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.