🇪🇺 VEGZELMA in European Union

EMA authorised VEGZELMA on 17 August 2022

Marketing authorisation

Application: EMEA/H/C/005534
Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
Local brand name: Vegzelma
Indication: VEGZELMA in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. VEGZELMA 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, please refer to section 5.1. VEGZELMA in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or
Pathway: biosimilar
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is VEGZELMA approved in European Union?

Yes. EMA authorised it on 17 August 2022.

Who is the marketing authorisation holder for VEGZELMA in European Union?

Celltrion Healthcare Hungary Kft. holds the EU marketing authorisation.