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

reach pharmaceuticals pty ltd - romidepsin, quantity: 10 mg - diluent, not applicable - excipient ingredients: propylene glycol; ethanol absolute - romidepsin-reach is indicated for the treatment of peripheral t-cell lymphoma in patients who have received at least one prior systemic therapy.

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

pfizer laboratories div pfizer inc - romidepsin (unii: cx3t89xqbk) (romidepsin - unii:cx3t89xqbk) - romidepsin 10 mg in 2 ml - romidepsin is indicated for the treatment of cutaneous t-cell lymphoma (ctcl) in adult patients who have received at least one prior systemic therapy. romidepsin is indicated for the treatment of peripheral t-cell lymphoma (ptcl) in adult patients who have received at least one prior therapy. this indication is approved under accelerated approval based on response rate [see clinical studies (14.2)]. continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none. risk summary based on its mechanism of action and findings from animal studies, romidepsin can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. in an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformati

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

teva parenteral medicines, inc. - romidepsin (unii: cx3t89xqbk) (romidepsin - unii:cx3t89xqbk) - romidepsin is indicated for the treatment of cutaneous t-cell lymphoma (ctcl) in adult patients who have received at least one prior systemic therapy. none. risk summary based on its mechanism of action and findings from animal studies, romidepsin can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. in an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see data). advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving romidepsin and for at least 1 month after the last dose. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth def

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

celgene pty ltd - romidepsin, quantity: 10 mg - injection, powder for - excipient ingredients: povidone; dilute hydrochloric acid - istodax is indicated for the treatment of peripheral t-cell lymphoma in patients who have received at least one prior systemic therapy.

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

teva parenteral medicines, inc. - romidepsin (unii: cx3t89xqbk) (romidepsin - unii:cx3t89xqbk) - romidepsin injection is indicated for the treatment of cutaneous t-cell lymphoma (ctcl) in adult patients who have received at least one prior systemic therapy. none. risk summary based on its mechanism of action and findings from animal studies, romidepsin injection can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. in an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see data) . advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving romidepsin and for at least 1 month after the last dose. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a backgrou

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

fresenius kabi usa, llc - romidepsin (unii: cx3t89xqbk) (romidepsin - unii:cx3t89xqbk) - romidepsin for injection is indicated for the treatment of cutaneous t-cell lymphoma (ctcl) in adult patients who have received at least one prior systemic therapy. none. risk summary based on its mechanism of action and findings from animal studies, romidepsin can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. in an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see data). advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving romidepsin and for at least 1 month after the last dose. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background ris

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

celgene corporation - romidepsin (unii: cx3t89xqbk) (romidepsin - unii:cx3t89xqbk) - romidepsin 10 mg in 2 ml - istodax is indicated for the treatment of cutaneous t-cell lymphoma (ctcl) in adult patients who have received at least one prior systemic therapy. none. risk summary based on its mechanism of action and findings from animal studies, istodax can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on istodax use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. in an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see data). advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving istodax and for at least 1 month after the last dose. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, o

Israel - English - Ministry of Health

teva israel ltd - romidepsin - solution for injection - romidepsin 5 mg/ml - romidepsin - romidepsin teva is indicated for the:- treatment of cutaneous t-cell lymphoma (ctcl) in patients who have received at least one prior systemic therapy. - treatment of peripheral t-cell lymphoma (ptcl) in patients who have received at least one prior therapy.

Israel - English - Ministry of Health

neopharm scientific ltd - romidepsin - powder and diluent for solution for injection - romidepsin 10 mg/vial - romidepsin - romidepsin - • treatment of cutaneous t-cell lymphoma (ctcl) in patients who have received at least one prior systemic therapy.• treatment of peripheral t-cell lymphoma (ptcl) in patients who have received at least one prior therapy.

Canada - English - Health Canada

bristol-myers squibb canada - romidepsin - kit - 10mg - romidepsin 10mg - antineoplastic agents