Iceland· IS-EU/1/15/1059/001
Orkambi
A ivacaftor and lumacaftor product containing lumacaftorum inn,ivacaftorum inn, registered in Iceland by Vertex Pharmaceuticals (Ireland) Limited. The same ATC class is registered in 16 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Lumacaftorum INN,Ivacaftorum INN
- Manufacturer
- Vertex Pharmaceuticals (Ireland) Limited
- Country
- Iceland (IS)
- ATC code
- R07AX30
- ATC class
- Ivacaftor and lumacaftor
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- United StatesORKAMBIVertex Pharmaceuticals 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
- IrelandOrkambi 100 mg/125 mg film-coated tabletsVertex Pharmaceuticals (Ireland) Limited
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/c7aa9481-18ca-4a72-b856-9a509990157d GET /v1/drugs/c7aa9481-18ca-4a72-b856-9a509990157d?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": "Filmuhúðuð tafla",
"source": "lyfjastofnun",
"atc_raw": "R07AX30",
"marketed": false,
"strength": "200 mg/125 mg",
"ma_number": "EU/1/15/1059/001",
"substance": "Lumacaftorum INN,Ivacaftorum INN",
"other_info": "Ávísun lyfsins er bundin við barnalækna með sérþekkingu á slímseigjusjúkdómi og sérfræðinga í lungnalækningum.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "42327"
}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.