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Medicines
Spain
Ivacaftor

AEMPS 2013

Ivacaftor

Kalydeco 150 MG Comprimido Recubierto con Pelicula

150 mg comprimido recubierto con películaSpainMarketedAuthorised 10 Jun 2013

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 · 150 MG · Tablet · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
KalydecoCanada · 75 MG / SACHET · Granules · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
KalydecoCanada · 25 MG / SACHET · Granules · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
KalydecoEuropean Union · Vertex Pharmaceuticals (Ireland) LimitedSame brand
KalydecoCroatiaSame brand
Kalydeco

More with the same substance on this register

Kalydeco 25 MG Granulado en SobreIvacaftor · 25 mg · granuladoSpain
Kalydeco 50 MG Granulado en SobreIvacaftor · 50 mg · granulado en sobreSpain

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.

Italy · Granulato · Vertex Pharmaceuticals (Ireland) Limited

Same brand

🇳🇱Kalydeco 150 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Vertex Pharmaceuticals (Ireland) LimitedSame brand

🇳🇱Kalydeco 75 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Vertex Pharmaceuticals (Ireland) LimitedSame brand

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

🇳🇿KalydecoNew Zealand · Tab 150 mgSame brand

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

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

🇷🇴KALYDECO 150 mgRomania · 150mg · compr. film. · Vertex Pharmaceuticals (Ireland) LimitedSame brand

🇷🇴KALYDECO 150 mgRomania · 150mg · compr. film. · Vertex Pharmaceuticals (Europe) LimitedSame brand

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

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

🇷🇸Kalydeco®Serbia · 150mg · film tableta · Vertex Pharmaceuticals Limited D.O.O.Same brand

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

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

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

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

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

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

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

🇺🇸IvacaftorUnited States · 150MG · tablet · Lupin LTDSame form

Packs

Pack	Code	Status
KALYDECO 150 MG COMPRIMIDO RECUBIERTO CON PELICULA 56 comprimidos	698265
KALYDECO 150 MG COMPRIMIDO RECUBIERTO CON PELICULA 28 comprimidos	724209

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: 150 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 10 Jun 2013
Registration: 112782002
Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
Procedure: EU centralised
Supply: Uso Hospitalario

AEMPSKalydeco 59,5 MG Granulado en SobreIvacaftor · 59,5 mg · granulado🇪🇸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