European Union - English - EMA (European Medicines Agency)

steba biotech s.a - padeliporfin di-potassium - prostatic neoplasms - antineoplastic agents - 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.

Israel - English - Ministry of Health

steba laboratories ltd., israel - padeliporfin dipotassium - powder for solution for infusion - padeliporfin dipotassium 200 mg - tookad soluble is indicated for adult patients with unilateral low risk localised prostate cancer and with a life expectancy ≥ 10 years and:- - clinical stage up to t2a, - gleason score ≤ 6, based on high-resolution biopsy strategies, - psa ≤ 10 ng/ml, - up to 3 independent positive cores- mpmri by 3t without endo-rectal coil showing normal mri or unilateral tumor without evidence of capsular or seminal vesicle involvement or metastatic tumor to lymph nodes.tookad is administered as part of focal vascular-targeted photodynamic therapy (vtp).

Israel - English - Ministry of Health

steba laboratories ltd., israel - padeliporfin dipotassium - powder for solution for infusion - padeliporfin dipotassium 400 mg - tookad soluble is indicated for adult patients with unilateral low risk localised prostate cancer and with a life expectancy ≥ 10 years and:- - clinical stage up to t2a, - gleason score ≤ 6, based on high-resolution biopsy strategies, - psa ≤ 10 ng/ml, - up to 3 independent positive cores- mpmri by 3t without endo-rectal coil showing normal mri or unilateral tumor without evidence of capsular or seminal vesicle involvement or metastatic tumor to lymph nodes.tookad is administered as part of focal vascular-targeted photodynamic therapy (vtp).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - indometacin - modified-release capsule - 75mg

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

meiji seika pharma co., ltd. - talaporfin sodium - injection