Ibrance
palbociclib
Table of contents
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.
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 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 |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
09/11/2016
|
Contact address |
Pfizer Europe MA EEIG |
Product information
26/05/2023 Ibrance - EMEA/H/C/003853 - 202208
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.