Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 30 November 2017

Indication(s)

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.

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More information

Category Value
Agency product number EMEA/H/C/004182
Orphan designation No
Date First Approved 21-09-2017
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder STEBA Biotech S.A