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Belgium· BE-AMP-SAM497244-00

Vylaer Spiromax 320 µg - 9 µg

A formoterol and budesonide product containing budesonide, registered in Belgium by Teva Pharma. The same ATC class is registered in 14 of our 19 countries.

ATC R03AK07

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedVylaer Spiromax 320 µg - 9 µgATCR03AK07REGISTER NO.BE-AMP-SAM497244-00PACKS LISTED0CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about budesonideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 9 of them publish a price we can compare per daily dose
Search formoterol and budesonide products by name

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

FAMHP / AFMPS (Belgium)
Active substance
Budesonide
Manufacturer
Teva Pharma
Country
Belgium (BE)
ATC code
R03AK07
ATC class
Formoterol and budesonide
Defined daily dose
24 mcg, Inhal
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 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

Formoterol and budesonide in 16 other countries

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

All formoterol and budesonide products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Budenofalk, Budo-San
  • Bulgaria · Airbudenid, Буденофалк
  • Cyprus · Axelovert, Biosonide
  • Czechia · Budenofalk, Budenofalk Uno
  • Germany · Aquacort, Budapp Nasal
  • Denmark · Benarhin, Budenofalk
  • Estonia · Budesonid Sandoz, Budesonide
  • Spain · Budena, Budesonida
  • 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 FAMHP / AFMPS (Belgium). 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/ac91088f-41ef-4a00-b0fa-1c516f1a84c2
GET /v1/drugs/ac91088f-41ef-4a00-b0fa-1c516f1a84c2?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": "Inhalation powder",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Vylaer Spiromax 320 µg - 9 µg",
  "name_fr": "Vylaer Spiromax 320 µg - 9 µg",
  "name_nl": "Vylaer Spiromax 320 µg - 9 µg",
  "amp_code": "SAM497244-00",
  "strengths": [
    "320.0000",
    "9.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Budesonide",
    "Formoterol Fumarate Dihydrate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Formoterol and Budesonide",
  "authorisation_numbers": [
    "EU/1/14/949/004"
  ]
}
API referenceMCP serverPlans

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.

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