Ibrance

RSS

palbociclib

Authorised
This medicine is authorised for use in the European Union.

Overview

Ibrance is a cancer medicine used to treat breast cancer when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). Ibrance can only be used when the cancer cells have receptors (targets) for certain hormones on their surface (HR-positive) and do not produce abnormally large quantities of a receptor called HER2 (HER [human epidermal growth factor] negative). Ibrance is used in the following ways:

  • together with an aromatase inhibitor (a hormonal medicine for cancer);
  • together with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.

In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.

Ibrance contains the active substance palbociclib.

This EPAR was last updated on 26/10/2022

Authorisation details

Product details
Name
Ibrance
Agency product number
EMEA/H/C/003853
Active substance
palbociclib
International non-proprietary name (INN) or common name
palbociclib
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE33
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG 
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
09/11/2016
Contact address

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

21/07/2022 Ibrance - EMEA/H/C/003853 - II/0038/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:

  • in combination with an aromatase inhibitor;
  • in combination with fulvestrant in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

Assessment history

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