Tezacaftor, Ivacaftor

Symkevi 100 MG/150 MG Comprimidos Recubiertos con Pelicula

100 mg + 150 mg comprimido recubierto con películaSpainMarketedAuthorised 17 Jan 2019

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.

SymkeviEuropean UnionAuthorised

SymkeviEuropean Union · Vertex Pharmaceuticals (Ireland) LimitedSame brand
SymkeviCroatiaSame brand
SymkeviItaly · Compressa rivestita con film · Vertex Pharmaceuticals (Ireland) LimitedSame brand
Symkevi 100 mg/150 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Vertex Pharmaceuticals (Ireland) LimitedSame brand
Symkevi 50 mg/ 75 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · 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.

Discover Osler

Tezacaftor, Ivacaftor

Symkevi 100 MG/150 MG Comprimidos Recubiertos con Pelicula

100 mg + 150 mg comprimido recubierto con películaSpainMarketedAuthorised 17 Jan 2019

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.

SymkeviEuropean 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

Symdeko

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

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

SymdekoBrazil · Vertex Farmaceutica do Brasil Ltda.

Packs

Pack	Code	Status
Symkevi 100mg/150mg comprimidos recubiertos con pelicula, 28 comprimidos	724212

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: Tezacaftor, Ivacaftor
Strength: 100 mg + 150 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 17 Jan 2019
Registration: 1181306001
Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/18/1306