Poland· PL-100446589
Symkevi
A ivacaftor and tezacaftor product containing tezacaftorum + ivacaftorum, registered in Poland by Vertex Pharmaceuticals (Ireland) Ltd.. The same ATC class is registered in 15 of our 19 countries.
Checked against URPL (Poland) on
Informational only — not a medical device.
Where it is registered
Ivacaftor and tezacaftor is registered in 15 of 19 countries.
Countries holding a registration under ATC R07AX31 (ivacaftor and tezacaftor), each read from that country’s own register.
- This record: Poland, from URPL (Poland)
- 10 of them publish a price we can compare per daily dose
Ivacaftor and tezacaftor · ATC R07AX31
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
The record
At a glance
URPL (Poland)- Active substance
- Tezacaftorum + Ivacaftorum
- Manufacturer
- Vertex Pharmaceuticals (Ireland) Ltd.
- Country
- Poland (PL)
- ATC code
- R07AX31
- ATC class
- Ivacaftor and tezacaftor
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin00351167144404
- gtin00351167201008
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ivacaftor and tezacaftor in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSYMKEVIVertex Pharmaceuticals (Ireland) Limited, Dublin
- FinlandSymkeviVERTEX PHARMACEUTICALS (Ireland) Limited
- SwitzerlandSymdeko 100 mg / 150 mg und 150 mg, FilmtablettenVertex Pharmaceuticals (CH) GmbH
- SpainSYMKEVI 100 MG/150 MG COMPRIMIDOS RECUBIERTOS CON PELICULAVertex Pharmaceuticals (Ireland) Limited
- FranceSYMKEVI 100 mg/150 mg, comprimé pelliculéVERTEX PHARMACEUTICALS (EUROPE) ROYAUME-UNI)
- United KingdomSymkevi 100mg/150mg tabletsVertex Pharmaceuticals (Europe) Ltd
- IrelandSymkevi 100 mg/150 mg Film-coated tabletVertex Pharmaceuticals (Ireland) Limited
- IcelandSymkeviVertex Pharmaceuticals (Ireland) Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Symkevi
- Liechtenstein · Symkevi
- Norway · Symkevi
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/3a2bd3f1-4b42-4e1c-8ef6-7eb88aeecbb7 GET /v1/drugs/3a2bd3f1-4b42-4e1c-8ef6-7eb88aeecbb7?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": "Tabletki powlekane",
"source": "urpl",
"strength": "50 mg + 75 mg",
"packaging": "00351167144404 ¦ Rpz ¦ EU/1/18/1306/002 ¦ 138941\n28 tabl.\n00351167201008 ¦ Rpz ¦ EU/1/18/1306/002 ¦ 164280\n28 tabl.",
"substance": "Tezacaftorum 50 mg + Ivacaftorum 75 mg",
"common_name": "Tezacaftorum + Ivacaftorum",
"pl_product_id": "100446589",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}See everything about ivacaftor and tezacaftor.
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.