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 |
10
|
| Date of issue of marketing authorisation valid throughout the European Union |
09/11/2016
|
| Contact address | |
Product information
13/02/2020 Ibrance - EMEA/H/C/003853 - X/0018
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.