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Belgium· BE-AMP-SAM567173-00

Enerzair Breezhaler 114 µg - 46 µg - 136 µg

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

ATC R03AL12

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedEnerzair Breezhaler 114 µg - 46 µg - …ATCR03AL12REGISTER NO.BE-AMP-SAM567173-00PACKS LISTED4CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about glycopyrronium bromideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Indacaterol, glycopyrronium bromid und mometason is registered in 11 of 19 countries.

Countries holding a registration under ATC R03AL12 (indacaterol, glycopyrronium bromid 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, glycopyrronium bromid und mometason products by name

Indacaterol, glycopyrronium bromid und mometason · ATC R03AL12

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.

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Glycopyrronium Bromide
Manufacturer
Novartis Europharm
Country
Belgium (BE)
ATC code
R03AL12
ATC class
Indacaterol, Glycopyrronium bromid und Mometason
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 4

1 priced
  • be_apb
    4242418
  • be_apb
    7730518
  • be_apb
    4242434
  • be_apb
    4242426
    EUR 163.89

Regulatory notes

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

Same medicine, other countries

Indacaterol, glycopyrronium bromid und mometason in 9 other countries

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

All indacaterol, glycopyrronium bromid und mometason products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Axhidrox, Glycopyrroniumbromid Accord
  • Bulgaria · Axhidrox, Амидил Амихалер
  • Cyprus · Glycopyrronium Bromide Accord, Robinul
  • Czechia · Amidil Amihaler, Axhidrox
  • Germany · Axhidrox, Glycopyrronium Axiromed
  • Denmark · Axhidrox, Glycopirronium Medical Valley
  • Estonia · Axhidrox
  • Finland · Axhidrox, Glykopyrroniumbromidi Accord
  • France · Glycopyrronium Biogaran, Glycopyrronium Wolff
  • United Kingdom (Northern Ireland) · Assicco, Glycopyrrolate Mercury Pharmaceuticals
  • Greece · Axhidrox, Glycopyrronium Verisfield
  • Croatia · Axhidrox
  • Hungary · Axhidrox, Rybrila
  • Ireland · Axhidrox, Glycopyrronium Bromide Ethypharm
  • Iceland · Seebri Breezhaler, Sialanar
  • Italy · Axhidrox, Glicopirronio Bromuro Accord
  • Liechtenstein · Seebri Breezhaler, Sialanar
  • Lithuania · Akshidroz
  • Luxembourg · Axhidroks, Robinul
  • Latvia · Axhidrox
  • Malta · Glycopyrronium Morningside
  • Netherlands · Axhidrox, Dusmyla
  • Norway · Axhidrox, Glycopirronium Medical Valley
  • Poland · Amidil Amihaler, Axhidrox
  • Portugal · Glicopirrónio Axidrox
  • Romania · Axhidrox
  • Sweden · Axhidrox, Glycopirronium Medical Valley
  • Slovenia · Axhidrox
  • Slovakia · Axhidrox

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/136680a4-92d9-4a48-952a-dd5e79173182
GET /v1/drugs/136680a4-92d9-4a48-952a-dd5e79173182?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": "Enerzair Breezhaler 114 µg - 46 µg - 136 µg",
  "name_fr": "Enerzair Breezhaler 114 µg - 46 µg - 136 µg",
  "name_nl": "Enerzair Breezhaler 114 µg - 46 µg - 136 µg",
  "amp_code": "SAM567173-00",
  "strengths": [
    "58.0000",
    "46.0000",
    "136.0000",
    "114.0000",
    "25.0000"
  ],
  "pack_count": 6,
  "substances": [
    "Glycopyrronium Bromide",
    "Glycopyrronium",
    "Mometasone Furoate",
    "Indacaterol Acetate",
    "Indacaterol",
    "Lactose Monohydrate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Indacaterol, Glycopyrronium Bromide and Mometasone",
  "authorisation_numbers": [
    "EU/1/20/1438/001",
    "EU/1/20/1438/002",
    "EU/1/20/1438/005",
    "EU/1/20/1438/003",
    "EU/1/20/1438/004"
  ]
}
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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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