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Ireland· IE-PA-PA23180/015/001

Bisolvon 4mg/5ml Oral Solution

A bromhexine product containing bromhexine hydrochloride, registered in Ireland by Opella Healthcare France SAS T/A Sanofi. The same ATC class is registered in 15 of our 19 countries.

ATC R05CB02

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedBisolvon 4mg/5ml Oral SolutionATCR05CB02REGISTER NO.IE-PA-PA23180/015/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about bromhexine hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Bromhexine is registered in 15 of 19 countries.

Countries holding a registration under ATC R05CB02 (bromhexine), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 8 of them publish a price we can compare per daily dose
Search bromhexine products by name

Bromhexine · ATC R05CB02

15 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
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
Bromhexine hydrochloride
Manufacturer
Opella Healthcare France SAS T/A Sanofi
Country
Ireland (IE)
ATC code
R05CB02
ATC class
Bromhexine
Defined daily dose
24 mg, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA23180/015/001

Regulatory notes

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

Same medicine, other countries

Bromhexine in 13 other countries

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

All bromhexine products

Authorised across Europe · EMA

The same active substance is authorised in 27 EEA countries. Names it is sold under:

  • Belgium · Bisolvon Schleimiger Husten, Bisolvon Slijmhoest
  • Bulgaria · Бромхексин Актавис, Бромхексин Дс
  • Cyprus · Flecoxin
  • Czechia · Bromhexin Berlin-Chemie, Bromhexin Egis
  • Germany · Bisolvon, Bisolvon Hustentabletten
  • Denmark · Bisolvon, Bromhexin "dak"
  • Estonia · Bromhexine Grindeks
  • Spain · Bisolvon Mucolítico, Bisolvon Mucolítico Infantil
  • Finland · Bisolvon, Bisolvon Strong
  • France · Bisolvon
  • Greece · Bisolvon, Bron-Hal
  • Croatia · Bisolex, Bisolex F
  • Hungary · Paxirasol
  • Iceland · Sinex
  • Italy · Bisolvon, Bisolvon Linctus Gusto Cioccolato-Ciliegia
  • Lithuania · Bromhexin Berlin-Chemie, Bromhexine Grindeks
  • Luxembourg · Bisolvon Toux Grasse, Toularynx Bromhexine
  • Latvia · Bromhexin Sopharma, Bromhexine Grindeks
  • Malta · Bisolvon, Bronchotussine
  • Netherlands · Albert Heijn Hoestdrank Broomhexine Hcl Healthypharm, Bisolvon
  • Norway · Bisolvon, Bromheksin Norfri
  • Poland · Flegafortan, Flegamina Baby
  • Portugal · Basiflux, Bisolin Adulto
  • Romania · Bromfluex, Bromhexin
  • Sweden · Bisolvon, Bisolvon Citron
  • Slovenia · Bisolvon
  • Slovakia · Bromhexin Bc, Bromhexin Berlin-Chemie

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/744d4da6-d54e-447a-bcdc-33f37a10d605
GET /v1/drugs/744d4da6-d54e-447a-bcdc-33f37a10d605?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": "Oral solution",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "R05CB",
    "R05CB02"
  ],
  "strength": null,
  "pa_number": "PA23180/015/001",
  "substances": [
    "Bromhexine hydrochloride"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Not marketed",
  "authorised_at": "14/11/1984",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

See everything about bromhexine.

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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