Malta - English - Malta Medicines Authority

lotus support services s.r.l. 47 theodor pallady blvd. 2nd office, entrance b, 1st floor 3rd district bucharest, romania - vinorelbine tartrate - soft capsule - vinorelbine tartrate 20 mg - antineoplastic agents

Malta - English - Malta Medicines Authority

lotus support services s.r.l. 47 theodor pallady blvd. 2nd office, entrance b, 1st floor 3rd district bucharest, romania - vinorelbine tartrate - soft capsule - vinorelbine tartrate 30 mg - antineoplastic agents

Malta - English - Malta Medicines Authority

lotus support services s.r.l. 47 theodor pallady blvd. 2nd office, entrance b, 1st floor 3rd district bucharest, romania - vinorelbine tartrate - soft capsule - vinorelbine tartrate 80 mg - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - vinorelbine tartrate - capsule, soft - vinorelbine

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - vinorelbine tartrate - capsule, soft - vinorelbine

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

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - vinorelbine tartrate 41.55mg equivalent to vinorelbine 30mg;   - capsule - 30 mg - active: vinorelbine tartrate 41.55mg equivalent to vinorelbine 30mg   excipient: gelatin iron oxide red 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - vinorelbine tartrate 110.8mg equivalent to vinorelbine 80mg;   - capsule - 80 mg - active: vinorelbine tartrate 110.8mg equivalent to vinorelbine 80mg   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.

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

hospira australia pty ltd - vinorelbine tartrate, quantity: 13.85 mg/ml - injection - excipient ingredients: water for injections - vinorelbine is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer (nsclc). in patients with stage iv nsclc, vinorelbine is indicated as a single agent or in combination with cisplatin. in stage iii nsclc, vinorelbine is indicated in combination with cisplatin.