Tookad

RSS

padeliporfin

Authorised
This medicine is authorised for use in the European Union.

Overview

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 29/11/2017

Authorisation details

Product details
Name
Tookad
Agency product number
EMEA/H/C/004182
Active substance
padeliporfin di-potassium
International non-proprietary name (INN) or common name
padeliporfin
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XD07
Additional 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
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
10/11/2017
Contact address
7 place du theatre
L-2613 Luxembourg
Luxembourg

Product information

21/09/2017 Tookad - EMEA/H/C/004182 -

Contents

  • 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.

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

How useful was this page?

Add your rating