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Ireland· IE-PA-PA22655/001/001

Osmohale, inhalation powder, hard capsule

A other diagnostic agents product containing mannitol, registered in Ireland by Pharmaxis Europe Limited. The same ATC class is registered in 11 of our 19 countries.

ATC V04CX

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedOsmohale, inhalation powder, hard cap…ATCV04CXREGISTER NO.IE-PA-PA22655/001/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Mannitol is registered in 11 of 19 countries.

Countries holding a registration under ATC V04CX (other diagnostic agents), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 7 of them publish a price we can compare per daily dose

Mannitol · ATC V04CX

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

HPRA (Ireland)
Active substance
Mannitol
Manufacturer
Pharmaxis Europe Limited
Country
Ireland (IE)
ATC code
V04CX
ATC class
Other diagnostic agents
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA22655/001/001

Regulatory notes

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

Same medicine, other countries

Mannitol in 16 other countries

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

All mannitol products

Authorised across Europe · EMA

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

  • Austria · Mannit Fresenius
  • Belgium · Mannitol Viaflo Baxter, Mannitol, Viaflo Baxter
  • Bulgaria · Манитол Б. Браун, Манитол Бакстер
  • Cyprus · Mannitol Demo, Mannitol Βιοσερ
  • Czechia · Ardeaosmosol Ma, Manitol Viaflo Baxter
  • Germany · Aridol, Mannit-Lösung Serag
  • Denmark · Mannitol Fresenius Kabi, Osmohale
  • Estonia · Mannitol Fresenius
  • Spain · Manitol Mein, Osmofundina
  • Finland · Aridol, Mannitol Braun
  • France · Mannitol Aguettant, Mannitol B. Braun
  • United Kingdom (Northern Ireland) · Mannitol Baxter Healthcare, Osmohale
  • Greece · Mannitol Bradex, Mannitol Cooper
  • Croatia · Manitol Hztm
  • Hungary · Mannisol A, Mannisol B
  • Iceland · Bronchitol, Mannitol Viaflo Baxter
  • Italy · Mannitolo Bioindustria L.I.M, Mannitolo Bioindustria L.I.M.
  • Liechtenstein · Bronchitol
  • Lithuania · Mannitol Fresenius
  • Luxembourg · Mannitol Viaflo, Mannitol Viaflo Baxter
  • Latvia · Mannitol Fresenius
  • Malta · Mannitol Baxter Holding, Mannitol Monico
  • Netherlands · Mannitol Baxter, Osmohale
  • Norway · Aridol, Bronchitol
  • Poland · Mannitol Baxter, Mannitol Fresenius
  • Portugal · Manitol Braun, Manitol Labesfal
  • Romania · Manitol Infomed Fluids, Mannitol Vioser
  • Sweden · Aridol, Mannitol Fresenius Kabi
  • Slovenia · Manitol Hztm
  • Slovakia · Infusio Mannitoli, Mannitol Bieffe

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 HPRA (Ireland). 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/e3666d1c-ce22-4778-871f-13660ce96153
GET /v1/drugs/e3666d1c-ce22-4778-871f-13660ce96153?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",
  "routes": [
    "Inhalation use"
  ],
  "source": "hpra",
  "atc_all": [
    "V04CX"
  ],
  "strength": null,
  "pa_number": "PA22655/001/001",
  "substances": [
    "Mannitol"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "12/10/2007",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about mannitol.

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.