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

spectrum pharmaceuticals, inc. - ibritumomab tiuxetan (unii: 4q52c550xk) (ibritumomab tiuxetan - unii:4q52c550xk) - ibritumomab tiuxetan 1.6 mg in 1 ml - zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular b-cell non-hodgkin's lymphoma (nhl). zevalin is indicated for the treatment of previously untreated follicular nhl in adult patients who achieve a partial or complete response to first-line chemotherapy. none. risk summary based on its radioactivity, y-90 zevalin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . immunoglobulins are known to cross the placenta. there are no available data on zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. advise women of childbearing potential to use adequate contraception for a minimum of twelve months. inform women who become pregnant while receiving zevalin of the potential fetal risks. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other

European Union - English - EMA (European Medicines Agency)

ceft biopharma s.r.o. - ibritumomab tiuxetan - lymphoma, follicular - therapeutic radiopharmaceuticals - zevalin is indicated in adults.[90y]-radiolabelled zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. the benefit of zevalin following rituximab in combination with chemotherapy has not been established.[90y]-radiolabelled zevalin is indicated for the treatment of adult patients with rituximab relapsedorrefractory cd20+ follicular b-cell non-hodgkin's lymphoma (nhl).

Canada - English - Health Canada

glaxosmithkline inc - tositumomab - solution - 14mg - tositumomab 14mg - antineoplastic agents

Canada - English - Health Canada

auro pharma inc - ibritumomab tiuxetan - kit - 3.2mg - ibritumomab tiuxetan 3.2mg - radioactive agents

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

acrotech biopharma inc - ibritumomab tiuxetan (unii: 4q52c550xk) (ibritumomab tiuxetan - unii:4q52c550xk) - zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular b-cell non-hodgkin's lymphoma (nhl). zevalin is indicated for the treatment of previously untreated follicular nhl in adult patients who achieve a partial or complete response to first-line chemotherapy. none. risk summary based on its radioactivity, y-90 zevalin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]  . immunoglobulins are known to cross the placenta. there are no available data on zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. advise women of childbearing potential to use adequate contraception for a minimum of twelve months. inform women who become pregnant while receiving zevalin of the potential fetal risks. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other

New Zealand - English - Medsafe (Medicines Safety Authority)

mundipharma new zealand ltd - ibritumomab tiuxetan 1.6 mg/ml - concentrate for infusion - 1.6 mg/ml - active: ibritumomab tiuxetan 1.6 mg/ml excipient: sodium chloride water for injection sodium acetate trihydrate water for injection albumin dibasic sodium phosphate dodecahydrate hydrochloric acid as 1n soln, ph adjustment monobasic potassium phosphate pentetic acid potassium chloride sodium chloride sodium hydroxide as 1n soln, ph adjustment water for injection - zevalin is indicated for the treatment of adult patients with cd20 positive indolent b-cell non-hodgkin's lymphoma (nhl) who have failed rituximab therapy.

Israel - English - Ministry of Health

bayer israel ltd - ibritumomab tiuxetan 1.6 mg/ml - kit for radiopharmaceutical preparation infusion - ibritumomab tiuxetan(90y) - the 90y radiolabelled zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. the benefit of zevalin following rituximab in combination with chemotherapy has not been established.the 90y - radiolabelled zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory cd20+ follicular b-cell non-hodgkin's lymphama ( nhl).

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

medi-physics inc. - indium chloride in-111 (unii: 58td96h03i) (indium cation in-111 - unii:wjz06c0h8l) - indium cation in-111 5 mci in 0.5 ml - indiclor indium in-111 chloride is indicated for radiolabeling of prostascint (capromab pendetide) in preparations used for in vivo diagnostic imaging procedures. indiclor is also indicated for radiolabeling zevalin (ibritumomab tiuxetan) in preparations used for radioimmunotherapy procedures. please refer to the package insert for prostascint or zevalin for information regarding the radiolabeled product. please refer to the package insert for prostascint or zevalin for this information on the final drug product.

Canada - English - Health Canada

hoffmann-la roche limited - rituximab - solution - 10mg - rituximab 10mg - antineoplastic agents

Canada - English - Health Canada

celltrion healthcare co ltd - rituximab - solution - 100mg - rituximab 100mg - antineoplastic agents