This medicine is authorised for use in the European Union.


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 06/06/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
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 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles

Product information

26/05/2023 Ibrance - EMEA/H/C/003853 - 202208

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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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