Iceland· IS-EU/1/18/1306/001
Symkevi
A ivacaftor and tezacaftor product containing tezacaftorum inn,ivacaftorum inn, registered in Iceland by Vertex Pharmaceuticals (Ireland) Limited. The same ATC class is registered in 15 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Tezacaftorum INN,Ivacaftorum INN
- Manufacturer
- Vertex Pharmaceuticals (Ireland) Limited
- Country
- Iceland (IS)
- ATC code
- R07AX31
- ATC class
- Ivacaftor and tezacaftor
- 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 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
- IrelandSymkevi 100 mg/150 mg Film-coated tabletVertex Pharmaceuticals (Ireland) Limited
- SwedenSymkevi 100 mg/150 mg Filmdragerad tablettVertex Pharmaceuticals Ireland Ltd
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- 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 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/27893d58-e083-4ee8-9381-d5cc0d460c05 GET /v1/drugs/27893d58-e083-4ee8-9381-d5cc0d460c05?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": "R07AX31",
"marketed": false,
"strength": "100 mg/150 mg",
"ma_number": "EU/1/18/1306/001",
"substance": "Tezacaftorum 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": "43404"
}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.