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
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
STEBA Biotech S.A
|Date of issue of marketing authorisation valid throughout the European Union||
21/09/2017 Tookad - EMEA/H/C/004182 -
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.