pertuzumab / trastuzumab

This medicine is authorised for use in the European Union.


Phesgo is a cancer medicine for treating adults with ‘HER2-positive’ breast cancer (where a protein called HER2 is found on the cancer cells).

It is used in combination with other cancer medicines in:

  • patients with early breast cancer (when the cancer has not spread to other parts of the body) at high risk of coming back, after they have surgery;
  • patients with locally advanced, inflammatory breast cancer or with early breast cancer at high risk of coming back, before they have surgery;
  • patients whose cancer that has come back locally after treatment and cannot be removed by surgery;
  • patients with metastatic breast cancer (cancer that has spread to other parts of the body).

Phesgo contains the active substances pertuzumab and trastuzumab. For more information about the use of Phesgo and the other medicines the patients will receive, see the package leaflet.

This EPAR was last updated on 02/03/2022

Authorisation details

Product details
Agency product number
Active substance
  • pertuzumab
  • trastuzumab
International non-proprietary name (INN) or common name
  • pertuzumab
  • trastuzumab
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
Roche Registration GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen

Product information

13/01/2022 Phesgo - EMEA/H/C/005386 - II/0004

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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 (EBC)

Phesgo is indicated for use in combination with chemotherapy in:

  • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
  • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence

Metastatic breast cancer (MBC)

Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Assessment history

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