Ireland· IE-PA-EU/1/15/1059/005
Orkambi 100 mg/125 mg film-coated tablets
A ivacaftor and lumacaftor product containing lumacaftor + ivacaftor, registered in Ireland by Vertex Pharmaceuticals (Ireland) Limited. The same ATC class is registered in 16 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Ivacaftor and lumacaftor is registered in 16 of 19 countries.
Countries holding a registration under ATC R07AX30 (ivacaftor and lumacaftor), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 11 of them publish a price we can compare per daily dose
Ivacaftor and lumacaftor · ATC R07AX30
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Lumacaftor + Ivacaftor
- Manufacturer
- Vertex Pharmaceuticals (Ireland) Limited
- Country
- Ireland (IE)
- ATC code
- R07AX30
- ATC class
- Ivacaftor and lumacaftor
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/15/1059/005
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ivacaftor and lumacaftor in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaORKAMBIVERTEX PHARMACEUTICALS (CANADA) INCORPORATED
- SwitzerlandOrkambi 100 mg / 125 mg, FilmtablettenVertex Pharmaceuticals (CH) GmbH
- CzechiaORKAMBIVertex Pharmaceuticals (Ireland) Limited, Dublin
- SpainORKAMBI 100 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULAVertex Pharmaceuticals (Ireland) Limited
- FinlandOrkambiVertex Pharmaceuticals (Ireland) Limited
- FranceORKAMBI 100 mg/125 mg, comprimé pelliculéVERTEX PHARMACEUTICALS (IRELAND)
- United KingdomOrkambi 100mg/125mg granules sachetsVertex Pharmaceuticals (Europe) Ltd
- United StatesORKAMBIVertex Pharmaceuticals Incorporated
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Orkambi
- Liechtenstein · Orkambi
- Norway · Orkambi
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/672c4229-67bd-4fe8-9734-faaf2cada9ea GET /v1/drugs/672c4229-67bd-4fe8-9734-faaf2cada9ea?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": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"R07AX",
"R07AX30"
],
"strength": null,
"pa_number": "EU/1/15/1059/005",
"substances": [
"Lumacaftor",
"Ivacaftor"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "08/01/2018",
"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 ivacaftor and lumacaftor.
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.