United States - English - NLM (National Library of Medicine)

nanjing chemlin biomedical science & technology co, ltd. - vorinostat (unii: 58ifb293ji) (vorinostat - unii:58ifb293ji) -

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - vorinostat (unii: 58ifb293ji) (vorinostat - unii:58ifb293ji) - vorinostat 100 mg - zolinza® is indicated for the treatment of cutaneous manifestations in patients with cutaneous t-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. none. risk summary based on its mechanism of action and findings from animal studies, zolinza can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are insufficient data on zolinza use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in animal reproduction studies, administration of vorinostat to pregnant rats and rabbits during the period of organogenesis caused adverse developmental outcomes at maternal exposures approximately 0.5 times the human exposure based on auc0-24 hours (see data) . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss,

United States - English - NLM (National Library of Medicine)

ax pharmaceutical corp - vorinostat (unii: 58ifb293ji) (vorinostat - unii:58ifb293ji) -

United States - English - NLM (National Library of Medicine)

bluebay shandong co.,ltd - vorinostat (unii: 58ifb293ji) (vorinostat - unii:58ifb293ji) -

United States - English - NLM (National Library of Medicine)

ax pharmaceutical corp - vorinostat (unii: 58ifb293ji) (vorinostat - unii:58ifb293ji) -

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - vorinostat, quantity: 100 mg - capsule - excipient ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - zolinza is indicated for the treatment of cutaneous manifestations in patients with cutaneous t-cell lymphoma (ctcl) who have progressive, persistent or recurrent disease subsequent to prior systemic therapies.

Canada - English - Health Canada

merck canada inc - vorinostat - capsule - 100mg - vorinostat 100mg - antineoplastic agents

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - vorinostat -

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme australia pty ltd - vorinostat -

Namibia - English - Namibia Medicines Regulatory Council

msd pty ltd - vorinostat - capsules - each capsule contains vorinostat 100,0 mg