Poland· PL-100492049
Orkambi
A ivacaftor and lumacaftor product containing lumacaftorum + ivacaftorum, registered in Poland by Vertex Pharmaceuticals (Ireland) Ltd.. The same ATC class is registered in 16 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Lumacaftorum + Ivacaftorum
- Manufacturer
- Vertex Pharmaceuticals (Ireland) Ltd.
- Country
- Poland (PL)
- ATC code
- R07AX30
- ATC class
- Ivacaftor and lumacaftor
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin03400930274101
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
- CzechiaORKAMBIVertex Pharmaceuticals (Ireland) Limited, Dublin
- United StatesORKAMBIVertex Pharmaceuticals Incorporated
- SwitzerlandOrkambi 100 mg / 125 mg, FilmtablettenVertex Pharmaceuticals (CH) GmbH
- 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
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 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/7033aa3f-d689-4f2b-8fd7-ce2c3a2fadd8 GET /v1/drugs/7033aa3f-d689-4f2b-8fd7-ce2c3a2fadd8?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": "Granulat w saszetce",
"source": "urpl",
"strength": "75 mg + 94 mg",
"packaging": "Rpz ¦ EU/1/15/1059/008 ¦ 152775\n56 saszetek \n¦ UR/Z/4c/009/24 - 03400930274101 ¦ UR/Z/4c/313/25 - 03400930274101",
"substance": "Lumacaftorum 75 mg + Ivacaftorum 94 mg",
"common_name": "Lumacaftorum + Ivacaftorum",
"pl_product_id": "100492049",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": 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.