Verzenios

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abemaciclib

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

Overview

Verzenios is a cancer medicine used to treat women with breast cancer that is advanced or has spread to other parts of the body (metastatic). It is also used to treat men and women with early breast cancer after surgery where the cancer has spread to the lymph nodes (node-positive) and display other features indicating a higher risk for the cancer to come back. Verzenios can only be used when the cancer cells have certain types of receptor (called hormone receptors) on their surface (HR-positive) and do not produce abnormally large quantities of another receptor called HER2 (HER2-negative).

It is used together with a hormonal medicine, such as tamoxifen, an aromatase inhibitor or fulvestrant.

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

Verzenios contains the active substance abemaciclib.

This EPAR was last updated on 21/04/2022

Authorisation details

Product details
Name
Verzenios
Agency product number
EMEA/H/C/004302
Active substance
abemaciclib
International non-proprietary name (INN) or common name
abemaciclib
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01EF03
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
Eli Lilly Nederland B.V.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
26/09/2018
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

01/04/2022 Verzenios - EMEA/H/C/004302 - II/0013

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

Early Breast Cancer

Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1).

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

Advanced or Metastatic Breast Cancer

Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.

Assessment history

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