🇪🇺 PH FDC SC in European Union

EMA authorised PH FDC SC on 21 December 2020

Marketing authorisation

EMA — authorised 21 December 2020

  • Application: EMEA/H/C/005386
  • Marketing authorisation holder: Roche Registration GmbH
  • Local brand name: Phesgo
  • 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 chemothera
  • Status: approved

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Frequently asked questions

Is PH FDC SC approved in European Union?

Yes. EMA authorised it on 21 December 2020.

Who is the marketing authorisation holder for PH FDC SC in European Union?

Roche Registration GmbH holds the EU marketing authorisation.