This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Tookad. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tookad.

For practical information about using Tookad, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 07/12/2022

Authorisation details

Product details
Agency product number
Active substance
padeliporfin di-potassium
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Prostatic 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
STEBA Biotech S.A
Date of issue of marketing authorisation valid throughout the European Union
Contact address

14a Rue des Bains
L-1212 Luxembourg

Product information

07/12/2022 Tookad - EMEA/H/C/004182 - IAIN/0020

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


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

Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and:

  • Clinical stage T1c or T2a;
  • Gleason Score ≤ 6, based on high-resolution biopsy strategies;
  • PSA ≤ 10 ng/mL;
  • 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm³.

Assessment history

Related content

How useful was this page?

Add your rating
2 ratings
2 ratings