Ivacaftor, Lumacaftor

Orkambi 200 MG/125 MG Comprimidos Recubiertos con Pelicula

125 mg + 200 mg comprimido recubierto con películaSpainMarketedAuthorised 7 Jul 2016

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.

OrkambiEuropean UnionAuthorised

OrkambiBrazil · Vertex Farmaceutica do Brasil Ltda.Same brand
OrkambiBrazil · Vertex Farmaceutica do Brasil Ltda.Same brand
OrkambiCanada · 125 MG + 200 MG · Tablet · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
OrkambiCanada · 125 MG + 100 MG · Tablet · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
OrkambiCanada · 125 MG / SACHET + 100 MG / SACHET · Granules · Vertex Pharmaceuticals (Canada) IncorporatedSame brand
OrkambiEuropean Union · 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, Lumacaftor

Orkambi 200 MG/125 MG Comprimidos Recubiertos con Pelicula

125 mg + 200 mg comprimido recubierto con películaSpainMarketedAuthorised 7 Jul 2016

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.

OrkambiEuropean 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

OrkambiCroatia

OrkambiItaly · Compressa rivestita con film · Vertex Pharmaceuticals (Ireland) Limited

Orkambi 100 mg/125 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Vertex Pharmaceuticals (Ireland) Limited

Orkambi 200 mg/125 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Vertex Pharmaceuticals (Ireland) Limited

Orkambi 100 mg/125 mg, Granulaat in sachetNetherlands · Granulaat · Vertex Pharmaceuticals (Ireland) Limited

OrkambiUnited States · 125MG; 100MG, 125MG; 200MG · tablet · Vertex Pharms INC

OrkambiUnited States · 125MG/PACKET; 100MG/PACKET, 188MG/PACKET; 150MG/PACKET, 94MG/PACKET; 75MG/PACKET · granule · Vertex Pharms INC

Packs

Pack	Code	Status
ORKAMBI 200 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 112 (4 x 28) comprimidos (multipack)	711541

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, Lumacaftor
Strength: 125 mg + 200 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 7 Jul 2016
Registration: 1151059001
Marketing authorisation holder: Vertex Pharmaceuticals (Ireland) Limited
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/15/1059

Spain

Orkambi 150 MG/188 MG Granulado en SobreIvacaftor + Lumacaftor · 150 mg + 188 mg · granuladoSpain

Orkambi 75 MG/94 MG Granulado en SobreIvacaftor + Lumacaftor · 75 mg + 94 mg · granuladoSpain