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Ireland· IE-PA-EU/1/13/902/001

Translarna

A ataluren product containing ataluren, registered in Ireland by PTC Therapeutics International Limited. The same ATC class is registered in 6 of our 19 countries.

ATC M09AX03

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedTranslarnaATCM09AX03REGISTER NO.IE-PA-EU/1/13/902/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about atalurenAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Ataluren is registered in 6 of 19 countries.

Countries holding a registration under ATC M09AX03 (ataluren), each read from that country’s own register.

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

Ataluren · ATC M09AX03

6 / 19 countries

  • Belgiumprice
  • Finlandprice
  • Franceprice
  • Ireland
  • Polandprice
  • 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
Ataluren
Manufacturer
PTC Therapeutics International Limited
Country
Ireland (IE)
ATC code
M09AX03
ATC class
Ataluren
Defined daily dose
2.8 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/13/902/001

Regulatory notes

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

Same medicine, other countries

Ataluren in 6 other countries

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

All ataluren products

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/ee902c45-135e-4ba1-8f0a-f476d5aa1bee
GET /v1/drugs/ee902c45-135e-4ba1-8f0a-f476d5aa1bee?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": "Granules for oral suspension",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "M09AX",
    "M09AX03"
  ],
  "strength": null,
  "pa_number": "EU/1/13/902/001",
  "substances": [
    "Ataluren"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "31/07/2014",
  "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
}
API referenceMCP serverPlans

See everything about ataluren.

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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