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Medicines
Spain
Abiraterone

AEMPS 2021

Abiraterone

Zytiga 500 MG Comprimidos Recubiertos con Pelicula

500 mg comprimido recubierto con películaSpainAuthorisedAuthorised 11 Nov 2021

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.

ZytigaBrazil · Janssen-Cilag Farmacêutica LtdaSame brand
Zytiga®Brazil · Janssen-Cilag Farmacêutica LtdaSame brand
ZytigaCanada · 250 MG · Tablet · Janssen INCSame brand
ZytigaCanada · 500 MG · Tablet · Janssen INCSame brand
ZytigaEuropean Union · Janssen-Cilag International N.V.Same brand
ZytigaCroatiaSame brand
ZytigaItaly · Compressa rivestita con film · Janssen-Cilag International N.V.Same brand
ZYTIGA 250 mg tablettenNetherlands · Tablet · Janssen-Cilag International NVSame brand

More with the same substance on this register

Abiraterona Accord 500 MG Comprimidos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con películaSpain
Abiraterona Cipla 500 MG Comprimidos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con película

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.

🇳🇱ZYTIGA 500 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand

🇳🇿ZytigaNew Zealand · Tab 250 mgSame brand

🇷🇴ZYTIGA 500 mgRomania · 500mg · compr. film. · JanssenSame brand

🇷🇸Zytiga®Serbia · 250mg · tableta · PredstavniŠTvo Janssen-Cilag KFT BeogradSame brand

🇸🇦Zytiga 250 TabletSaudi Arabia · PatheonSame brand

🇸🇦ZYTIGA 500 Film-coated TabletSaudi Arabia · Patheon JallieuSame brand

🇸🇬Zytiga Film-Coated Tablet 500MGSingapore · 500mg · tablet, film coated · Johnson & Johnson International (Singapore) Pte LTDSame brand

🇸🇬Zytiga Tablet 250 mgSingapore · 250mg · tablet · Johnson & Johnson International (Singapore) Pte LTDSame brand

🇹🇼ZYTIGA® Film-Coated Tablets 500mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇹🇼ZYTIGA Tablets 250mgTaiwan · 錠劑 · 嬌生股份有限公司Same brand

🇹🇼ZYTIGA® Film-Coated Tablets 250mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇺🇸ZytigaUnited States · 250MG, 500MG · tablet · Janssen BiotechSame brand

🇦🇷EnordenArgentina · 250 MG · comprimido · Finadiet S.A.C.I. e I.Same form

🇨🇦Apo-Abiraterone Film Coated TabletsCanada · 250 MG · Tablet · Apotex INCSame form

🇭🇷Abirateron Alpha-Medical 500 mg filmom obložene tableteCroatia · filmom obložena tableta · Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, HrvatskaSame form

🇭🇷Abirateron MSN 500 mg filmom obložene tableteCroatia · Filmom obložena tableta · MSN Labs Europe Limited, Kw20a Corradino Park, Paola, MaltaSame form

🇮🇹Abiraterone AbdiItaly · Compressa · Abdi Farma GmbHSame form

🇮🇹Abiraterone Abdi FarmaItaly · Compressa rivestita con film · Abdi Farma GmbHSame form

🇳🇱Abirateron 1A Pharma 1000 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · 1A Pharma GmbHSame form

🇷🇸AbesineSerbia · 250mg · film tableta · Rhei Life DOOSame form

🇷🇸AbesineSerbia · 250mg · film tableta · Rhei Life DOOSame form

🇸🇦Abiraterone SPC 250MG F.C.TabletSaudi Arabia · Sudair Pharma CompanySame form

🇸🇬Abiraccord Tablets 250 MGSingapore · 250 mg · tablet · Accord Healthcare Private LimitedSame form

🇺🇸Abiraterone AcetateUnited States · 125MG, 250MG, 500MG · tablet · HikmaSame form

🇺🇸YonsaUnited States · 125MG · tablet · Sun PharmSame form

🇧🇷AbmethaBrazil · Cristália Produtos Químicos Farmacêuticos Ltda.Same substance

🇪🇺Abiraterone AccordEuropean Union · Accord Healthcare S.L.U.Same substance

🇪🇺Abiraterone KrkaEuropean Union · Krka, d.d., Novo mestoSame substance

Packs

Pack	Code	Status
ZYTIGA 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 60 comprimidos	732135

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: Abiraterone
Strength: 500 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 11 Nov 2021
Registration: 111714003IP
Marketing authorisation holder: Janssen-Cilag International N.V
Procedure: EU centralised
Supply: Diagnóstico Hospitalario

🇪🇸Spain

AEMPSAbiraterona DR. Reddys 500 MG Comprimidos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAbiraterona Glenmark 500 MG Comprimidos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAbiraterona Kern Pharma 500 MG Comprimidos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSABIRATERONA KRKA 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAbiraterona Mylan 1000 MG Comprimidos Recubiertos con PeliculaAbiraterone · 1000 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAbiraterona Normon 500 MG Comprimidos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAbiraterona Qilu 500 MG Comprimidos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAbiraterona Sandoz 500 MG Comprimdos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAbiraterona Stada 500 MG Comprimidos Recubiertos con Pelicula EfgAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAbiraterona Tarbis 500 MG Comprimidos Recubiertos con Película EfgAbiraterone · 500 mg · comprimido recubierto con película🇪🇸Spain