Ivacaftor, Tezacaftor, Elexacaftor

Kaftrio 75 MG/50 MG/100 MG Granulado en Sobre

75 mg + 50 mg + 100 mg granulado en sobreSpainMarketedAuthorised 14 Dec 2023

Product informationAsk Osler about it

In other countries

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

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

KaftrioEuropean UnionAuthorised

KaftrioEuropean Union · Vertex Pharmaceuticals (Ireland) LimitedSame brand
KaftrioCroatiaSame brand
KaftrioItaly · Compressa rivestita con film · Vertex Pharmaceuticals (Ireland) LimitedSame brand
Kaftrio 60mg/40mg/80mg granulaat in sachetNetherlands · Granulaat · Vertex Pharmaceuticals (Ireland) LimitedSame brand
Kaftrio 75 mg/50mg/100mg granulaat in sachetNetherlands · Granulaat · Vertex Pharmaceuticals (Ireland) LimitedSame brand

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.

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Ivacaftor, Tezacaftor, Elexacaftor

Kaftrio 75 MG/50 MG/100 MG Granulado en Sobre

75 mg + 50 mg + 100 mg granulado en sobreSpainMarketedAuthorised 14 Dec 2023

Product informationAsk Osler about it

In other countries

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

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

KaftrioEuropean UnionAuthorised

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.

Discover Osler

Kaftrio 100 mg/50 mg/75 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Vertex Pharmaceuticals (Ireland) Limited

Kaftrio®Serbia · 60mg+40mg+80mg · granule · Vertex Pharmaceuticals Limited D.O.O.

Kaftrio®Serbia · 75mg+50mg+100mg · granule · Vertex Pharmaceuticals Limited D.O.O.

TrikaftaCanada · 80 MG + 60 MG + 59.5 MG + 40 MG · Granules · Vertex Pharmaceuticals (Canada) Incorporated

TrikaftaCanada · 100 MG + 75 MG + 75 MG + 50 MG · Granules · Vertex Pharmaceuticals (Canada) Incorporated

Trikafta (Copackaged)United States · 100MG, 75MG, 50MG; 75MG, 80MG, 60MG, 40MG; 59.5MG · granule · Vertex Pharms INC

TrikaftaBrazil · Vertex Farmaceutica do Brasil Ltda.

TrikaftaCanada · 100 MG + 75 MG + 150 MG + 50 MG · Tablet · Vertex Pharmaceuticals (Canada) Incorporated

Trikafta (Copackaged)United States · 100MG,75MG,50MG; 150MG, 50MG,37.5MG,25MG; 75MG · tablet · Vertex Pharms INC

Packs

Pack	Code	Status
KAFTRIO 75 MG/50 MG/100 MG GRANULADO EN SOBRE, 28 sobres	763898

Documents

The official texts, at the regulator.

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 substances: Ivacaftor, Tezacaftor, Elexacaftor
Strength: 75 mg + 50 mg + 100 mg
Dosage form: granulado en sobre
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 14 Dec 2023
Registration: 1201468004
Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/20/1468

Spain

Kaftrio 75 MG/50 MG/100 MG Comprimidos Recubiertos con PeliculaIvacaftor + Tezacaftor + Elexacaftor · 50 mg + 75 mg + 100 mg · comprimido recubierto con películaSpain