enfortumab vedotin

This medicine is authorised for use in the European Union.


Padcev is a cancer medicine for treating adults with urothelial cancer (a cancer of the bladder and urinary tract).

Padcev is for patients whose cancer is advanced or has spread and who have already had platinum- based chemotherapy and an immunotherapy.

It contains the active substance enfortumab vedotin.

This EPAR was last updated on 08/05/2023

Authorisation details

Product details
Agency product number
Active substance
Enfortumab vedotin
International non-proprietary name (INN) or common name
enfortumab vedotin
Therapeutic area (MeSH)
  • Carcinoma, Transitional Cell
  • Urologic 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
Astellas Pharma Europe B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

26/04/2023 Padcev - EMEA/H/C/005392 - II/0007

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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

Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Assessment history

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