Canada - anglais - Health Canada

dr reddy's laboratories ltd - cabazitaxel - solution - 40mg - cabazitaxel 40mg - antineoplastic agents

Israël - anglais - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - cabazitaxel - concentrate and solvent for solution for infusion - cabazitaxel 40 mg/ml - cabazitaxel - cabazitaxel s.k. is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel- containing treatment regimen.

Israël - anglais - Ministry of Health

sanofi israel ltd - cabazitaxel - concentrate and solvent for solution for infusion - cabazitaxel 60 mg / 1.5 ml - cabazitaxel - cabazitaxel - jevtana is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel- containing treatment regimen.

États-Unis - anglais - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - cabazitaxel (unii: 51f690397j) (cabazitaxel - unii:51f690397j) - cabazitaxel 60 mg in 1.5 ml - jevtana® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. jevtana is contraindicated in patients with: - neutrophil counts of ≤1,500/mm3 [see warnings and precautions (5.1)] - history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 [see warnings and precautions (5.3)] - severe hepatic impairment (total bilirubin >3 × uln) [see warnings and precautions (5.8)] risk summary the safety and efficacy of jevtana have not been established in females. there are no human data on the use of jevtana in pregnant women to inform the drug-associated risk. in animal reproduction studies, intravenous administration of cabazitaxel in pregnant rats during organogenesis caused embryonic and fetal death at doses lower than the maximum recommended human dose [see data] . data animal data in an early embryonic developmental toxicity stu

Singapour - anglais - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - cabazitaxel - infusion, solution concentrate - 60mg/1.5ml - cabazitaxel 60mg/1.5ml

Union européenne - anglais - EMA (European Medicines Agency)

sanofi winthrop industrie - cabazitaxel - prostatic neoplasms - antineoplastic agents - jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Irlande - anglais - HPRA (Health Products Regulatory Authority)

ever valinject gmbh - cabazitaxel - concentrate for solution for infusion - 10 milligram(s)/millilitre - cabazitaxel

Union européenne - anglais - EMA (European Medicines Agency)

accord healthcare s.l.u. - cabazitaxel - prostatic neoplasms, castration-resistant - antineoplastic agents - treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.