Apalutamide

Erleada 60 MG Comprimidos Recubiertos con Pelicula

60 mg comprimido recubierto con películaSpainMarketedAuthorised 3 Feb 2019

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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.

ErleadaEuropean UnionAuthorised

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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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Apalutamide

Erleada 60 MG Comprimidos Recubiertos con Pelicula

60 mg comprimido recubierto con películaSpainMarketedAuthorised 3 Feb 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.

ErleadaEuropean 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

Erleada 240 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NV

Erleada 60 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NV

ERLEADA 60 mgRomania · 60mg · compr. film. · Janssen - Cilag International NV

Erleada®Serbia · 60mg · film tableta · PredstavniŠTvo Janssen-Cilag KFT Beograd

ERLEADA 60 mg Film-coated TabletSaudi Arabia · Janssen Ortho LLC

Erleada Film-Coated Tablet 60MGSingapore · 60mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTD

Erleada Film-Coated Tablets 60mgTaiwan · 膜衣錠 · 嬌生股份有限公司

ErleadaUnited States · 240MG, 60MG · tablet · Janssen Biotech

ApalutamideUnited States · 60MG · tablet · Zydus

Packs

Pack	Code	Status
ERLEADA 60 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 112 comprimidos	724602

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 substance: Apalutamide
Strength: 60 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 3 Feb 2019
Registration: 1181342001
Marketing authorisation holder: Janssen-Cilag International N.V
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/18/1342

Spain

Erleada 60 MG Comprimidos Recubiertos con PeliculaApalutamide · 60 mg · comprimido recubierto con películaSpain