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Poland· PL-100325816

Translarna

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

ATC M09AX03

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedTranslarnaATCM09AX03REGISTER NO.PL-100325816PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about atalurenumAnswers 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: Poland, from URPL (Poland)
  • 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

URPL (Poland)
Active substance
Atalurenum
Manufacturer
PTC Therapeutics International Limited
Country
Poland (PL)
ATC code
M09AX03
ATC class
Ataluren
Defined daily dose
2.8 g, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 2

  • gtin
    05909991276614
  • gtin
    05391528830510

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 URPL (Poland). 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/f750ea7f-07c9-48d9-a4c3-73d67ba29399
GET /v1/drugs/f750ea7f-07c9-48d9-a4c3-73d67ba29399?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": "Granulki do przygotowywania zawiesiny doustnej",
  "source": "urpl",
  "strength": "1000 mg",
  "packaging": "05909991276614 ¦ Rpz ¦ Skasowane ¦ EU/1/13/902/003 ¦ 104004\n30 sasz. \n05391528830510 ¦ Rpz ¦ EU/1/13/902/003 ¦ 134693\n30 sasz.",
  "substance": "Atalurenum 1000 mg",
  "common_name": "Atalurenum",
  "pl_product_id": "100325816",
  "pozwolenie_nr": null,
  "auth_procedure": "CEN",
  "authorisation_validity": "2025-03-28"
}
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.

Try it freeOpen in the console