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Medicines
Spain
Palbociclib

AEMPS 2020

Palbociclib

Ibrance 100 MG Comprimidos Recubiertos con Pelicula

100 mg comprimido recubierto con películaSpainAuthorisedAuthorised 29 Apr 2020

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.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

IbranceEuropean UnionAuthorised

IbranceBrazil · Pfizer Brasil LtdaSame brand
IbranceBrazil · Pfizer Brasil LtdaSame brand
IbranceBrazil · Laboratórios Pfizer LtdaSame brand
IbranceCanada · 75 MG · Tablet · Pfizer Canada UlcSame brand
IbranceCanada · 100 MG · Tablet · Pfizer Canada UlcSame brand
IbranceCanada · 125 MG · Tablet · Pfizer Canada UlcSame brand

More with the same substance on this register

Ibrance 100 MG Capsulas DurasPalbociclib · 100 mg · cápsula duraSpain
Ibrance 125 MG Capsulas DurasPalbociclib · 125 mg · cápsula duraSpain

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.

Ibrance

European Union · Pfizer Europe MA EEIG

Same brand

🇭🇷IbranceCroatiaSame brand

🇮🇹IbranceItaly · Capsula rigida · Pfizer Europe Ma EeigSame brand

🇳🇱Ibrance 100 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Pfizer Europe MA EEIGSame brand

🇳🇱Ibrance 125 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Pfizer Europe MA EEIGSame brand

🇳🇱Ibrance 75 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Pfizer Europe MA EEIGSame brand

🇷🇴IBRANCE 100 mgRomania · 100mg · caps. · Pfizer Europe Ma EeigSame brand

🇷🇴IBRANCE 100mgRomania · 100mg · caps. · Pfizer LimitedSame brand

🇷🇴IBRANCE 125 mgRomania · 125mg · caps. · Pfizer Europe Ma EeigSame brand

🇷🇸Ibrance®Serbia · 75mg · film tableta · Pfizer SRB D.O.O.Same brand

🇷🇸Ibrance®Serbia · 100mg · film tableta · Pfizer SRB D.O.O.Same brand

🇷🇸Ibrance®Serbia · 125mg · film tableta · Pfizer SRB D.O.O.Same brand

🇸🇦IbranceSaudi Arabia · Pfizer Manufacturing Deutschland GmbHSame brand

🇸🇦IBRANCE 100 mg capsuleSaudi Arabia · Pfizer Manufacturing Deutschland GmbHSame brand

🇸🇦IBRANCE 125 mg capsuleSaudi Arabia · Pfizer Manufacturing Deutschland GmbHSame brand

🇸🇬Ibrance Film Coated Tablet 100MGSingapore · 100 mg · tablet, film coated · Pfizer Private LimitedSame brand

🇸🇬Ibrance Film Coated Tablet 125MGSingapore · 125 mg · tablet, film coated · Pfizer Private LimitedSame brand

🇸🇬Ibrance Film Coated Tablet 75MGSingapore · 75 mg · tablet, film coated · Pfizer Private LimitedSame brand

🇺🇸IbranceUnited States · 100MG, 125MG, 75MG · tablet · PfizerSame brand

🇺🇸IbranceUnited States · 100MG, 125MG, 75MG · capsule · PfizerSame brand

🇭🇷Palbociklib Corapharm 100 mg filmom obložene tableteCroatia · Filmom obložena tableta · Corapharm d.o.o. , Alfreda Hilla 18, Vukovar, HrvatskaSame form

🇭🇷Palbociklib Corapharm 125 mg filmom obložene tableteCroatia · Filmom obložena tableta · Corapharm d.o.o. , Alfreda Hilla 18, Vukovar, HrvatskaSame form

🇳🇿Palbociclib PfizerNew Zealand · Tab 100 mgSame form

🇳🇿Palbociclib PfizerNew Zealand · Tab 125 mgSame form

🇳🇿Palbociclib PfizerNew Zealand · Tab 75 mgSame form

🇺🇸PalbociclibUnited States · 100MG, 125MG, 75MG · tablet · Zydus LifesciencesSame form

🇪🇺Palbociclib ViatrisEuropean Union · Viatris LimitedSame substance

Packs

Pack	Code	Status
IBRANCE 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 21 comprimidos	728236

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: Palbociclib
Strength: 100 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 29 Apr 2020
Registration: 1161147012
Marketing authorisation holder: Pfizer Europe Ma Eeig
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/16/1147

AEMPS

Ibrance 75 MG Capsulas DurasPalbociclib · 75 mg · cápsula dura🇪🇸Spain

AEMPSIbrance 100 MG Capsulas DurasPalbociclib · 100 mg · cápsula dura🇪🇸Spain

AEMPSIbrance 125 MG Capsulas DurasPalbociclib · 125 mg · cápsula dura🇪🇸Spain

AEMPSIbrance 125 MG Comprimidos Recubiertos con PeliculaPalbociclib · 125 mg · comprimido recubierto con película🇪🇸Spain

AEMPSIbrance 75 MG Capsulas DurasPalbociclib · 75 mg · cápsula dura🇪🇸Spain

AEMPSIbrance 75 MG Comprimidos Recubiertos con PeliculaPalbociclib · 75. mg · comprimido recubierto con película🇪🇸Spain