Skip to content

Sign in Start free

Create your free account

Loading your page…

We care for the people who care.

No ads. No selling of your data. No third-party trackers.

Apps

Prognia
Ward
Suture
Osler

Library

Guidelines
Medicines
Articles
Calculators
Explore decks
Institutions
Pharmaceutical companies
Blog

Prognia

About
Pricing
Contact

Support us

Founders Wall

© 2026 Prognia · Amsterdam, the NetherlandsPrivacy TermsExchangeRate-API

Loading…

Medicines
Spain
Ivacaftor

AEMPS 2023

Ivacaftor

Kalydeco 59,5 MG Granulado en Sobre

59,5 mg granuladoSpainMarketedAuthorised 14 Dec 2023

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

KalydecoBrazil · Vertex Farmaceutica do Brasil Ltda.Same brand
KalydecoBrazil · Vertex Farmaceutica do Brasil Ltda.Same brand
KalydecoCanada · 75 MG / SACHET · Granules · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
KalydecoCanada · 25 MG / SACHET · Granules · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
KalydecoCanada · 13.4 MG / SACHET · Granules · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
KalydecoEuropean Union · Vertex Pharmaceuticals (Ireland) LimitedSame brand
KalydecoCroatiaSame brand

More with the same substance on this register

Kalydeco 150 MG Comprimido Recubierto con PeliculaIvacaftor · 150 mg · comprimido recubierto con películaSpain
Kalydeco 25 MG Granulado en SobreIvacaftor · 25 mg · granuladoSpain

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Kalydeco

Italy · Granulato · Vertex Pharmaceuticals (Ireland) Limited

Same brand

🇳🇱Kalydeco 13,4 mg granulaat in sachetNetherlands · Granulaat · Vertex Pharmaceuticals (Ireland) LimitedSame brand

🇳🇱Kalydeco 25 mg granulaat in sachetNetherlands · Granulaat · Vertex Pharmaceuticals (Ireland) LimitedSame brand

🇳🇱Kalydeco 50 mg granulaat in sachetNetherlands · Granulaat · Vertex Pharmaceuticals (Ireland) LimitedSame brand

🇳🇿KalydecoNew Zealand · Oral granules 13.4 mg, sachetSame brand

🇳🇿KalydecoNew Zealand · Oral granules 75 mg, sachetSame brand

🇳🇿KalydecoNew Zealand · Oral granules 50 mg, sachetSame brand

🇷🇴KALYDECO 50 mgRomania · 50mg · granule · Vertex Pharmaceuticals (Europe) LimitedSame brand

🇷🇴KALYDECO 50 mgRomania · 50 mg · granule · Vertex Pharmaceuticals (Ireland) LimitedSame brand

🇷🇴KALYDECO 75 mgRomania · 75mg · granule · Vertex Pharmaceuticals (Europe) LimitedSame brand

🇷🇸Kalydeco®Serbia · 75mg · granule · Vertex Pharmaceuticals Limited D.O.O.Same brand

🇷🇸Kalydeco®Serbia · 59.5mg · granule · Vertex Pharmaceuticals Limited D.O.O.Same brand

🇷🇸Kalydeco®Serbia · 59.5mg · granule · Vertex Pharmaceuticals Limited D.O.O.Same brand

🇺🇸KalydecoUnited States · 13.4MG/PACKET, 25MG/PACKET, 5.8MG/PACKET … · granule · Vertex Pharms INCSame brand

🇺🇸KalydecoUnited States · 150MG · tablet · Vertex PharmsSame brand

🇺🇸IvacaftorUnited States · 25MG, 50MG, 75MG · granule · Lupin LTDSame form

🇭🇷Ivakaftor Accord 150 mg filmom obložene tableteCroatia · Filmom obložena tableta · Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, PoljskaSame substance

🇭🇷Ivakaftor Galenika 150 mg filmom obložene tabletaCroatia · Filmom obložena tableta · Galenika International Kft., Baross utca 165/3, Budaörs, MađarskaSame substance

🇮🇹DaskiferaItaly · Compressa rivestita con film · Day Zero EhfSame substance

🇮🇹Ivacaftor AccordItaly · Compressa rivestita con film · Accord Healthcare, S.L.U.Same substance

Packs

Pack	Code	Status
KALYDECO 59,5 MG GRANULADO EN SOBRE, 28 sobres	763908

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Ivacaftor
Strength: 59,5 mg
Dosage form: granulado
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 14 Dec 2023
Registration: 112782008
Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
Procedure: EU centralised
Supply: Uso Hospitalario

AEMPSKalydeco 50 MG Granulado en SobreIvacaftor · 50 mg · granulado en sobre🇪🇸Spain

AEMPSKalydeco 75 MG Comprimidos Recubiertos con PeliculaIvacaftor · 93,75 mg · comprimido recubierto con película🇪🇸Spain

AEMPSKalydeco 75 MG Granulado en SobreIvacaftor · 75 mg · granulado en sobre🇪🇸Spain

AEMPSIvacaftor Accord 150 MG Comprimidos Recubiertos con Pelicula EfgIvacaftor · 150 mg · comprimido recubierto con película🇪🇸Spain

AEMPSIvacaftor Aurovitas 150 MG Comprimidos Recubiertos con Película EfgIvacaftor · 150 mg · comprimido recubierto con película🇪🇸Spain

AEMPSIvacaftor Intas 150 MG Comprimidos Recubiertos con Pelicula EfgIvacaftor · 150 mg · comprimido recubierto con película🇪🇸Spain

AEMPSIvacaftor Stada 150 MG Comprimidos Recubiertos con Película EfgIvacaftor · 150 mg · comprimido recubierto con película🇪🇸Spain

AEMPSIvacaftor Sun 150 MG Comprimidos Recubiertos con Pelicula EfgIvacaftor · 150 mg · comprimido recubierto con película🇪🇸Spain

AEMPSIvacaftor Teva 150 MG Comprimidos Recubiertos con Pelicula EfgIvacaftor · 150 mg · comprimido recubierto con película🇪🇸Spain

AEMPSKalydeco 150 MG Comprimido Recubierto con PeliculaIvacaftor · 150 mg · comprimido recubierto con película🇪🇸Spain