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Belgium· BE-AMP-SAM567342-00

Atectura Breezhaler 125 µg - 260 µg

A indacaterol und mometason product containing indacaterol acetate, registered in Belgium by Novartis Europharm. The same ATC class is registered in 11 of our 19 countries.

ATC R03AK14

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedAtectura Breezhaler 125 µg - 260 µgATCR03AK14REGISTER NO.BE-AMP-SAM567342-00PACKS LISTED3CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about indacaterol acetateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Indacaterol und mometason is registered in 11 of 19 countries.

Countries holding a registration under ATC R03AK14 (indacaterol und mometason), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 7 of them publish a price we can compare per daily dose
Search indacaterol und mometason products by name

Indacaterol und mometason · ATC R03AK14

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
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.

Price per daily dose

What a daily dose of indacaterol und mometason costs, country by country.

Normalised to the WHO defined daily dose (0.15 mg), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Indacaterol und mometason · price per daily dose (0.15 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$1.85
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Indacaterol Acetate
Manufacturer
Novartis Europharm
Country
Belgium (BE)
ATC code
R03AK14
ATC class
Indacaterol und Mometason
Defined daily dose
0.15 mg, Inhal
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

1 priced
  • be_apb
    4237145
  • be_apb
    7730484
  • be_apb
    4237269
    EUR 93.17

Regulatory notes

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

Same medicine, other countries

Indacaterol und mometason in 13 other countries

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

All indacaterol und mometason products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Hirobriz Breezhaler, Onbrez Breezhaler
  • Liechtenstein · Hirobriz Breezhaler, Onbrez Breezhaler
  • Norway · Hirobriz Breezhaler, Onbrez Breezhaler

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/84d77f44-470d-4724-8ff2-13c07c81d0af
GET /v1/drugs/84d77f44-470d-4724-8ff2-13c07c81d0af?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, hard capsule",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Atectura Breezhaler 125 µg - 260 µg",
  "name_fr": "Atectura Breezhaler 125 µg - 260 µg",
  "name_nl": "Atectura Breezhaler 125 µg - 260 µg",
  "amp_code": "SAM567342-00",
  "strengths": [
    "260.0000",
    "125.0000",
    "125.0000",
    "260.0000",
    "125.0000",
    "25.0000"
  ],
  "pack_count": 5,
  "substances": [
    "Indacaterol Acetate",
    "Mometasone Furoate",
    "Indacaterol",
    "Lactose Monohydrate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Indacaterol and Mometasone",
  "authorisation_numbers": [
    "EU/1/20/1439/009",
    "EU/1/20/1439/012",
    "EU/1/20/1439/010",
    "EU/1/20/1439/011",
    "EU/1/20/1439/015"
  ]
}
API referenceMCP serverPlans

See everything about indacaterol und mometason.

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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