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Ireland· IE-PA-PA22680/004/001

Erdotin 300 mg capsules

A erdosteine product containing erdosteine, registered in Ireland by Galen Pharma Ireland Limited. The same ATC class is registered in 8 of our 19 countries.

ATC R05CB15

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedErdotin 300 mg capsulesATCR05CB15REGISTER NO.IE-PA-PA22680/004/001PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Erdosteine is registered in 8 of 19 countries.

Countries holding a registration under ATC R05CB15 (erdosteine), each read from that country’s own register.

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

Erdosteine · ATC R05CB15

8 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Ireland
  • Polandprice
  • 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.

Price per daily dose

What a daily dose of erdosteine costs, country by country.

Normalised to the WHO defined daily dose (0.6 g), 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

Erdosteine · price per daily dose (0.6 g)

USD · FX 28 Sept 2026

  • CH Switzerland$1.54
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

HPRA (Ireland)
Active substance
Erdosteine
Manufacturer
Galen Pharma Ireland Limited
Country
Ireland (IE)
ATC code
R05CB15
ATC class
Erdosteine
Defined daily dose
0.6 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA22680/004/001

Regulatory notes

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

Same medicine, other countries

Erdosteine in 6 other countries

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

All erdosteine products

Authorised across Europe · EMA

The same active substance is authorised in 15 EEA countries. Names it is sold under:

  • Austria · Erdomed
  • Belgium · Mucodox
  • Bulgaria · Ердомед, Ердосек
  • Czechia · Edinosier, Erdomed
  • Denmark · Erdotin
  • Finland · Erdopect
  • United Kingdom (Northern Ireland) · Erdotin
  • Greece · Theovix
  • Hungary · Erdomed
  • Italy · Erdotin, Esteclin
  • Luxembourg · Mucodox
  • Poland · Asterdan, Ebromen
  • Portugal · Milid
  • Romania · Erdomed
  • Slovakia · Edinosier, Erdomed

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/8e98212e-450f-4a21-ad6a-9b7c79a522cc
GET /v1/drugs/8e98212e-450f-4a21-ad6a-9b7c79a522cc?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": "Capsule, hard",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "R05CB",
    "R05CB15"
  ],
  "strength": null,
  "pa_number": "PA22680/004/001",
  "substances": [
    "Erdosteine"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "13/10/2006",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about erdosteine.

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.