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.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
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_numberPA22655/001/001
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.
- CzechiaARDEAOSMOSOL MA 10%ARDEAPHARMA, a.s., Ševětín
- United KingdomBronchitol 40mg inhalation powder capsules with deviceChapper Healthcare
- NorwayAridolPharmaxis Europe Limited
- United StatesMannitolFresenius Kabi USA, LLC
- GermanyAridolPharmaxis Europe Limited
- FranceMANNITOL 10 % AGUETTANT, solution pour perfusionAGUETTANT
- SwitzerlandMannitol 20 % Braun, InfusionslösungB. Braun Medical AG
- CanadaARIDOLPHARMAXIS EUROPE LIMITED
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.