Sweden· SE-20221222000034
Kalydeco 13,4 mg Granulat i dospåse
A medicinal product containing ivacaftor, registered in Sweden by Vertex Pharmaceuticals Ireland Ltd.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Ivacaftor
- Manufacturer
- Vertex Pharmaceuticals Ireland Ltd
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20221222000034
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ivacaftor in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandKalydeco 13.4 mg, GranulatVertex Pharmaceuticals (CH) GmbH
- CzechiaKALYDECOVertex Pharmaceuticals (Ireland) Limited, Dublin
- FinlandKalydecoVertex Pharmaceuticals (Ireland) Limited
- FranceKALYDECO 13,4 mg, granulés en sachetVERTEX PHARMACEUTICALS (EUROPE) LIMITED
- United KingdomKalydeco 13.4mg granules sachetsVertex Pharmaceuticals (Europe) Ltd
- IrelandKalydeco 13.4 mg granules in sachetVertex Pharmaceuticals (Ireland) Limited
- NetherlandsKalydeco 13,4 mg granulaat in sachetVertex Pharmaceuticals (Ireland) Limited
- NorwayKalydecoVertex Pharmaceuticals (Ireland) Limited
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Ivacaftor Accord, Ivacaftor Stada
- Belgium · Ivacaftor Ab, Ivacaftor Accord
- Cyprus · Vaftor
- Czechia · Ivacaftor Accord
- Germany · Ivacaftor Al, Ivacaftor Basics
- Denmark · Ivacaftor "stada", Ivacaftor Accord
- Estonia · Ivacaftor Stada
- Spain · Ivacaftor Accord, Ivacaftor Aurovitas
- Finland · Ivacaftor Accord, Ivacaftor Stada Stada
- France · Ivacaftor Accord, Ivacaftor Arrow
- United Kingdom (Northern Ireland) · Ivacaftor Lupin Healthcare (Uk)
- Greece · Ivacaftor Win Medica, Qulventra
- Croatia · Ivacaftor Accord, Ivakaftor Galenika
- Hungary · Ivacaftor Galenika, Ivacaftor Stada
- Iceland · Kalydeco
- Italy · Ivacaftor Accord, Ivacaftor Sun
- Liechtenstein · Kalydeco
- Lithuania · Ivacaftor Stada
- Luxembourg · Ivacaftor Ab, Ivacaftor Eg
- Latvia · Ivacaftor Stada, Ivacaftor Teva
- Malta · Fidasercot, Flidepartoc
- Netherlands · Ivacaftor Aurobindo, Ivacaftor Intas
- Norway · Ivacaftor Accord, Ivacaftor Lupin Europe Gmbh
- Poland · Ivacaftor Accord, Ivacaftor Ranbaxy
- Portugal · Ivacaftor Accord, Ivacaftor Generis
- Romania · Ivacaftor Stada, Ivacaftor Sun
- Slovenia · Ivakaftor Accord, Ivakaftor Galenika
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 Swedish Medical Products Agency (Sweden). 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/d9a7b87e-81c5-4abb-a118-419c9b65e9b6 GET /v1/drugs/d9a7b87e-81c5-4abb-a118-419c9b65e9b6?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.
{
"source": "lakemedelsverket",
"doc_types": [
"Dispensbeslut"
],
"se_npl_id": "20221222000034",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20221222000034",
"product_doc_link": "https://docetp.mpa.se/LMF/Kalydeco%2C%20dosp%C3%A5sar%2C%2056%20st%2C%20sammanfattning%20av%20beslut%2C%20giltigt%20fr.o.m.%202026-07-07%20t.o.m.%202028-06-09_09001bee851b175e.pdf"
}See everything about ivacaftor.
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.