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Ireland· IE-PA-EU/1/12/782/004

Kalydeco 75 mg granules in sachet

A other respiratory system products product containing ivacaftor, registered in Ireland by Vertex Pharmaceuticals (Ireland) Limited. The same ATC class is registered in 6 of our 19 countries.

ATC R07AX

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedKalydeco 75 mg granules in sachetATCR07AXREGISTER NO.IE-PA-EU/1/12/782/004PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ivacaftorAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Ivacaftor is registered in 6 of 19 countries.

Countries holding a registration under ATC R07AX (other respiratory system products), 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 ivacaftor products by name

Ivacaftor · ATC R07AX

6 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Ireland
  • Netherlands
  • Polandprice
  • Switzerlandprice
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
Ivacaftor
Manufacturer
Vertex Pharmaceuticals (Ireland) Limited
Country
Ireland (IE)
ATC code
R07AX
ATC class
Other respiratory system products
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/12/782/004

Regulatory notes

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

Same medicine, other countries

Ivacaftor in 16 other countries

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

All ivacaftor products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Ivacaftor Accord, Ivacaftor Stada
  • Belgium · Ivacaftor Ab, Ivacaftor Accord
  • Cyprus · Vaftor
  • Czechia · Ivacaftor Accord
  • Germany · Ivacaftor Al, Ivacaftor Basics
  • Denmark · Ivacaftor "stada", Ivacaftor Accord
  • Estonia · Ivacaftor Stada
  • Spain · Ivacaftor Accord, Ivacaftor Aurovitas
  • Finland · Ivacaftor Accord, Ivacaftor Stada Stada
  • France · Ivacaftor Accord, Ivacaftor Arrow
  • United Kingdom (Northern Ireland) · Ivacaftor Lupin Healthcare (Uk)
  • Greece · Ivacaftor Win Medica, Qulventra
  • Croatia · Ivacaftor Accord, Ivakaftor Galenika
  • Hungary · Ivacaftor Galenika, Ivacaftor Stada
  • Iceland · Kalydeco
  • Italy · Ivacaftor Accord, Ivacaftor Sun
  • Liechtenstein · Kalydeco
  • Lithuania · Ivacaftor Stada
  • Luxembourg · Ivacaftor Ab, Ivacaftor Eg
  • Latvia · Ivacaftor Stada, Ivacaftor Teva
  • Malta · Fidasercot, Flidepartoc
  • Netherlands · Ivacaftor Aurobindo, Ivacaftor Intas
  • Norway · Ivacaftor Accord, Ivacaftor Lupin Europe Gmbh
  • Poland · Ivacaftor Accord, Ivacaftor Ranbaxy
  • Portugal · Ivacaftor Accord, Ivacaftor Generis
  • Romania · Ivacaftor Stada, Ivacaftor Sun
  • Sweden · Fidasercot, Flidepartoc
  • Slovenia · Ivakaftor Accord, Ivakaftor Galenika

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/92294365-91a4-4f66-a874-345b26a4321d
GET /v1/drugs/92294365-91a4-4f66-a874-345b26a4321d?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 in sachet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "R07AX"
  ],
  "strength": null,
  "pa_number": "EU/1/12/782/004",
  "substances": [
    "Ivacaftor"
  ],
  "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "16/11/2015",
  "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 ivacaftor.

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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