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Medicines
Spain
Ibrutinib

AEMPS 2019

Ibrutinib

Imbruvica 420 MG Comprimidos Recubiertos con Pelicula

420 mg comprimido recubierto con películaSpainMarketedAuthorised 24 Oct 2019

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.

ImbruvicaBrazil · Janssen-Cilag Farmacêutica LtdaSame brand
ImbruvicaBrazil · Janssen-Cilag Farmacêutica LtdaSame brand
ImbruvicaBrazil · Janssen-Cilag Farmacêutica LtdaSame brand
ImbruvicaCanada · 560 MG · Tablet · Janssen INCSame brand
ImbruvicaCanada · 140 MG · Tablet · Janssen INCSame brand
ImbruvicaCanada · 420 MG · Tablet · Janssen INCSame brand
ImbruvicaEuropean Union · Janssen-Cilag International NVSame brand
ImbruvicaCroatiaSame brand

More with the same substance on this register

Imbruvica 140 MG Capsulas DurasIbrutinib · 140 mg · cápsula duraSpain
Imbruvica 140 MG Comprimidos Recubiertos con PeliculaIbrutinib · 140 mg · comprimido recubierto con películaSpain

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.

🇮🇹ImbruvicaItaly · Compressa rivestita con film · Janssen-Cilag International N.V.Same brand

🇳🇱IMBRUVICA 140 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand

🇳🇱IMBRUVICA 280 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand

🇳🇱IMBRUVICA 420 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand

🇳🇿ImbruvicaNew Zealand · Tab 140 mgSame brand

🇳🇿ImbruvicaNew Zealand · Tab 420 mgSame brand

🇷🇴IMBRUVICA 140 mgRomania · 140mg · caps. · JanssenSame brand

🇷🇴IMBRUVICA 140 mgRomania · 140 mg · compr. film. · Janssen Cilag SPASame brand

🇷🇴IMBRUVICA 280 mgRomania · 280 mg · compr. film. · Janssen Cilag SPASame brand

🇷🇸Imbruvica®Serbia · 140mg · kapsula, tvrda · PredstavniŠTvo Janssen-Cilag KFT BeogradSame brand

🇸🇦ImbruvicaSaudi Arabia · Janssen-CilagSame brand

🇸🇦IMBRUVICA 140 mg capsuleSaudi Arabia · CatalentSame brand

🇸🇬Imbruvica Film-Coated Tablets 140MGSingapore · 140mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame brand

🇹🇼Imbruvica Capsules 140mgTaiwan · 膠囊劑 · 嬌生股份有限公司Same brand

🇹🇼Imbruvica Film-Coated Tablets 140 mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇹🇼Imbruvica Film-Coated Tablets 280 mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇺🇸ImbruvicaUnited States · 140MG, 230MG, 280MG … · tablet · Pharmacyclics LLCSame brand

🇺🇸ImbruvicaUnited States · 70MG/ML · suspension · Pharmacyclics LLCSame brand

🇺🇸ImbruvicaUnited States · 140MG, 70MG · capsule · Pharmacyclics LLCSame brand

🇦🇷VilanorArgentina · 140 MG · cápsula dura · Tuteur S.A.C.I.F.I.ASame substance

🇸🇦DullarmaSaudi Arabia · The Arab Pharmaceutical Manufacturing PSC (Sahab) Co LtdSame substance

Packs

Pack	Code	Status
IMBRUVICA 420 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 30 comprimidos	726956

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: Ibrutinib
Strength: 420 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 24 Oct 2019
Registration: 114945005
Marketing authorisation holder: Janssen-Cilag International N.V
Procedure: EU centralised
Supply: Diagnóstico Hospitalario

🇪🇸

AEMPSImbruvica 280 MG Comprimidos Recubiertos con PeliculaIbrutinib · 280 mg · comprimido recubierto con película🇪🇸Spain

AEMPSImbruvica 560 MG Comprimidos Recubiertos con PeliculaIbrutinib · 560 mg · comprimido recubierto con película🇪🇸Spain

AEMPSImbruvica 140 MG Capsulas DurasIbrutinib · 140 mg · cápsula dura🇪🇸Spain