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Ireland· IE-PA-EU/1/24/1883/001-002

AUGTYRO 40 mg hard capsules

A repotrectinib product containing repotrectinib, registered in Ireland by Bristol-Myers Squibb Pharma EEIG. The same ATC class is registered in 10 of our 19 countries.

ATC L01EX28

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedAUGTYRO 40 mg hard capsulesATCL01EX28REGISTER NO.IE-PA-EU/1/24/1883/00…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Repotrectinib is registered in 10 of 19 countries.

Countries holding a registration under ATC L01EX28 (repotrectinib), each read from that country’s own register.

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

Repotrectinib · ATC L01EX28

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • United Statesprice
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
Repotrectinib
Manufacturer
Bristol-Myers Squibb Pharma EEIG
Country
Ireland (IE)
ATC code
L01EX28
ATC class
Repotrectinib
Defined daily dose
0.32 g, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/24/1883/001-002

Regulatory notes

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

Same medicine, other countries

Repotrectinib in 9 other countries

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

All repotrectinib products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Augtyro
  • Liechtenstein · Augtyro
  • Norway · Augtyro

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/dee0d0cf-63fe-4997-9436-4cd260d4af6b
GET /v1/drugs/dee0d0cf-63fe-4997-9436-4cd260d4af6b?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": [
    "L01EX28"
  ],
  "strength": null,
  "pa_number": "EU/1/24/1883/001-002",
  "substances": [
    "Repotrectinib"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "13/01/2025",
  "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 repotrectinib.

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.