Malta - English - Medicines Authority

strides arcolab international limited unit 4, metro centre, tolpits lane, watford, hertfordshire, wd 189 ss, united kingdom - vinorelbine tartrate - concentrate for solution for infusion - vinorelbine tartrate 10 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

strides arcolab international limited unit 4, metro centre, tolpits lane, watford, hertfordshire, wd 189 ss, united kingdom - vinorelbine tartrate - concentrate for solution for infusion - vinorelbine tartrate 10 mg/ml - antineoplastic agents

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

hospira australia pty ltd - vinorelbine tartrate -

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

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

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

hospira australia pty ltd - vinorelbine tartrate -

Israel - English - Ministry of Health

trima trading (1961), israel - vinorelbine as tartrate - concentrate for solution for infusion - vinorelbine as tartrate 10 mg/ml - vinorelbine - for the treatment of non small cell lung cancer. for the treatment of advanced breast cancer.hormone - refractory prostate cancer, especially in combination with low dose oral corticoid therapy or estramustin.

Israel - English - Ministry of Health

devries & co. ltd - vinorelbine as tartrate - concentrate for solution for infusion - vinorelbine as tartrate 10 mg/ml - vinorelbine - for the treatment of non small cell lung cancer. for the treatment of advanced breast cancer. hormone- refractory prostate cancer, especially in combination with low dose oral corticoid therapy or estramustin.

Malta - English - Medicines Authority

accord healthcare limited - vinorelbine tartrate - concentrate for solution for infusion - vinorelbine tartrate 10 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - vinorelbine tartrate - concentrate for solution for infusion - vinorelbine tartrate 10 mg/ml - antineoplastic agents