Ireland· IE-PA-EU/1/18/1306/001
Symkevi 100 mg/150 mg Film-coated tablet
A ivacaftor and tezacaftor product containing tezacaftor + ivacaftor, registered in Ireland by Vertex Pharmaceuticals (Ireland) Limited. The same ATC class is registered in 15 of our 19 countries.
Checked against HPRA (Ireland) 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: Ireland, from HPRA (Ireland)
- 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
HPRA (Ireland)- Active substance
- TEZACAFTOR + Ivacaftor
- Manufacturer
- Vertex Pharmaceuticals (Ireland) Limited
- Country
- Ireland (IE)
- ATC code
- R07AX31
- ATC class
- Ivacaftor and tezacaftor
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/18/1306/001
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.
- FinlandSymkeviOrifarm Oy
- SwitzerlandSymdeko 100 mg / 150 mg und 150 mg, FilmtablettenVertex Pharmaceuticals (CH) GmbH
- CzechiaSYMKEVIVertex Pharmaceuticals (Ireland) Limited, Dublin
- 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
- SwedenSymkevi 100 mg/150 mg Filmdragerad tablettVertex Pharmaceuticals Ireland Ltd
- NorwaySymkeviVertex 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 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/ce8887d4-1d09-44e7-b5a1-e115185ef3b7 GET /v1/drugs/ce8887d4-1d09-44e7-b5a1-e115185ef3b7?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": [
"R07AX31"
],
"strength": null,
"pa_number": "EU/1/18/1306/001",
"substances": [
"TEZACAFTOR",
"Ivacaftor"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "31/10/2018",
"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 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.