Spain· ES:112782003
KALYDECO 50 MG GRANULADO EN SOBRE
A medicinal product containing ivacaftor, registered in Spain by Vertex Pharmaceuticals (Ireland) Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- ivacaftor
- Manufacturer
- Vertex Pharmaceuticals (Ireland) Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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 in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumKalydeco 50 mgVertex Pharmaceuticals (Ireland)
- CanadaKALYDECOVERTEX PHARMACEUTICALS (CANADA) INCORPORATED
- SwitzerlandKalydeco
- CzechiaKALYDECOVertex Pharmaceuticals (Ireland) Limited, Dublin
- FinlandKalydecoVertex Pharmaceuticals (Ireland) Limited
- FranceKALYDECO 50 mg, granulés en sachetVERTEX PHARMACEUTICALS (IRELAND)
- United KingdomKalydeco 50mg granules sachetsVertex Pharmaceuticals (Europe) Ltd
- IrelandKalydeco 50 mg granules in sachetVertex 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
- 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
- Sweden · Fidasercot, Flidepartoc
- 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 AEMPS CIMA (Spain). 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/2a3576d4-69a3-4c30-998b-42966e636676 GET /v1/drugs/2a3576d4-69a3-4c30-998b-42966e636676?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1467928800000}",
"nregistro": "112782003",
"substance": "ivacaftor"
}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.