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

pierre fabre medicament australia pty ltd - vinorelbine tartrate -

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - vinorelbine tartrate 13.85mg equivalent to to 10 mg vinorelbine - concentrate for injection - 10 mg/ml - active: vinorelbine tartrate 13.85mg equivalent to to 10 mg vinorelbine excipient: nitrogen water for injection - dbl™ vinorelbine injection concentrate is indicated as a single agent or in combination for 1. the treatment of non small cell lung cancer (nsclc), and 2. the second line treatment of advanced breast cancer.

Malta - English - Medicines Authority

remedica limited limassol industrial estate, aharnon street, 3056 limassol, cyprus - nifedipine - film-coated tablet - nifedipine 10 mg - cardiac therapy

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

teva parenteral medicines, inc. - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml

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

hospira, inc. - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - vinorelbine injection, usp is indicated: none pregnancy category d risk summary vinorelbine can cause fetal harm when administered to a pregnant woman. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. animal data in a mouse embryofetal development study, administration of a single dose of vinorelbine at a dose level of 9 mg/m2 or greater (approximately 0.33 times the recommended human dose based on body surface area) was embryotoxic and fetotoxic. vinorelbine was embryotoxic and fetotoxic to pregnant rabbits when administered every 6 days during the period of organogenesis at doses of 5.5 mg/m2 (approximately 0.18 times the recommended human dose based on body surface area) or greater. at doses t

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

ingenus pharmaceuticals, llc - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine injection is indicated: -   in combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) -   as a single agent for the treatment of patients with metastatic nsclc none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], vinorelbine injection can cause fetal harm when administered to a pregnant woman. available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see data). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are

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

actavis pharma, inc. - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - vinorelbine injection is indicated: - in combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) - as a single agent for the treatment of patients with metastatic nsclc none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], vinorelbine can cause fetal harm when administered to a pregnant woman. available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see data). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 1

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

pierre fabre pharmaceuticals, inc. - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - navelbine is a vinca alkaloid indicated: - in combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) - as a single agent, for the treatment of patients with metastatic nsclc none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1))] , navelbine can cause fetal harm when administered to a pregnant woman. available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively ( see data ). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies ar

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

sagent pharmaceuticals - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - vinorelbine injection is indicated: - in combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) - as a single agent for the treatment of patients with metastatic nsclc none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , vinorelbine can cause fetal harm when administered to a pregnant woman. available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - vinorelbine tartrate 27.7mg equivalent to vinorelbine 20mg;   - capsule - 20 mg - active: vinorelbine tartrate 27.7mg equivalent to vinorelbine 20mg   excipient: gelatin iron oxide yellow macrogol 400 polysorbate 80 purified water   sorbitol titanium dioxide - vinorelbine is indicated in adults over 18. for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.