Table of contents
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.
Tookad : EPAR - Summary for the public (PDF/75.57 KB)
First published: 29/11/2017
Last updated: 29/11/2017
Tookad : EPAR - Risk-management-plan summary (PDF/543.54 KB)
First published: 01/02/2021
Last updated: 02/03/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
STEBA Biotech S.A
|Date of issue of marketing authorisation valid throughout the European Union||
14a Rue des Bains
07/12/2022 Tookad - EMEA/H/C/004182 - IAIN/0020
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
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.