Zirabev

RSS

bevacizumab

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

Overview

Zirabev is a cancer medicine that is used to treat adults with the following cancers:

  • cancer of the colon (large bowel) or the rectum (the last section of the bowel), when it has spread to other parts of the body;
  • breast cancer that has spread to other parts of the body;
  • a lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery. Zirabev can be used unless the cancer originates in particular cells called squamous cells;
  • cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
  • cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.

Zirabev is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect how well particular medicines work.

Zirabev contains the active substance bevacizumab and it is a ‘biosimilar medicine’. This means that Zirabev is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Zirabev is Avastin. For more information on biosimilar medicines, see here.

This EPAR was last updated on 18/11/2019

Authorisation details

Product details
Name
Zirabev
Agency product number
EMEA/H/C/004697
Active substance
bevacizumab
International non-proprietary name (INN) or common name
bevacizumab
Therapeutic area (MeSH)
  • Colorectal Neoplasms
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Uterine Cervical Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC07
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.

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
14/02/2019
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

31/10/2019 Zirabev - EMEA/H/C/004697 - IAIN/0003

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.

Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status.

Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.

Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.

Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Assessment history

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