Australien - engelska - Department of Health (Therapeutic Goods Administration)

pierre fabre australia pty ltd - vinorelbine tartrate, quantity: 110.8 mg (equivalent: vinorelbine, qty 80 mg) - capsule, soft - excipient ingredients: ethanol; purified water; glycerol; macrogol 400; gelatin; iron oxide yellow; titanium dioxide; medium chain triglycerides; ascorbyl palmitate; phosphatidyl choline; dl-alpha-tocopherol; sorbitol; 1,4-sorbitan; mannitol; hydrogenated starch hydrosylate; hypromellose; propylene glycol; isopropyl alcohol; aluminium chloride; sodium hydroxide; cochineal - non-small cell lung cancer: navelbine oral is indicated for first line treatment of advanced non-small cell lung cancer, as a single agent or in combination.,breast cancer: navelbine oral is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

pierre fabre australia pty ltd - vinorelbine tartrate, quantity: 41.55 mg (equivalent: vinorelbine, qty 30 mg) - capsule, soft - excipient ingredients: ethanol; purified water; glycerol; macrogol 400; gelatin; iron oxide red; titanium dioxide; medium chain triglycerides; ascorbyl palmitate; phosphatidyl choline; dl-alpha-tocopherol; sorbitol; 1,4-sorbitan; mannitol; hydrogenated starch hydrosylate; hypromellose; propylene glycol; isopropyl alcohol; aluminium chloride; sodium hydroxide; cochineal - non-small cell lung cancer: navelbine oral is indicated for first line treatment of advanced non-small cell lung cancer, as a single agent or in combination.,breast cancer: navelbine oral is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

pierre fabre australia pty ltd - vinorelbine tartrate, quantity: 27.7 mg (equivalent: vinorelbine, qty 20 mg) - capsule, soft - excipient ingredients: ethanol; purified water; glycerol; macrogol 400; gelatin; iron oxide yellow; titanium dioxide; medium chain triglycerides; ascorbyl palmitate; phosphatidyl choline; dl-alpha-tocopherol; sorbitol; 1,4-sorbitan; mannitol; hydrogenated starch hydrosylate; hypromellose; propylene glycol; isopropyl alcohol; aluminium chloride; sodium hydroxide; cochineal - non-small cell lung cancer: navelbine oral is indicated for first line treatment of advanced non-small cell lung cancer, as a single agent or in combination.,breast cancer: navelbine oral is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

pierre fabre australia pty ltd - vinorelbine tartrate, quantity: 13.85 mg/ml (equivalent: vinorelbine, qty 10 mg/ml) - injection, concentrated - excipient ingredients: water for injections - navelbine is indicated for the treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination; and as first line treatment for advanced non-small cell lung cancer, as a single agent or in combination. navelbine is indicated for the treatment, in combination with cisplatin, of patients with completely resected non-small cell lung cancer of stage ib or greater.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

pierre fabre australia pty ltd - vinorelbine tartrate, quantity: 13.85 mg/ml (equivalent: vinorelbine, qty 10 mg/ml) - injection, concentrated - excipient ingredients: water for injections - navelbine is indicated for the treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination; and as first line treatment for advanced non-small cell lung cancer, as a single agent or in combination. navelbine is indicated for the treatment, in combination with cisplatin, of patients with completely resected non-small cell lung cancer of stage ib or greater.

USA - engelska - NLM (National Library of Medicine)

janssen products lp - erdafitinib (unii: 890e37nhmv) (erdafitinib - unii:890e37nhmv) - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc) with susceptible fgfr3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. select patients for therapy based on an fda-approved companion diagnostic for balversa [see dosage and administration (2.1)and clinical studies (14.1)] . limitations of use balversa is not recommended for the treatment of patients who are eligible for and have not received prior pd-1 or pd-l1 inhibitor therapy [see clinical studies (14.1)] . none. risk summary based on the mechanism of action and findings in animal reproduction studies, balversa can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on balversa use in pregnant women to inform a drug-associated risk. oral administration of erdafitinib to pregnant rats during organogenesis caused malformations and embryo-fetal death at maternal exposures that were less than the human exposures at the maximum recommended human dose based on auc (see data ). advise pregnant women and females of reproductive potential of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data in an embryo-fetal toxicity study, erdafitinib was orally administered to pregnant rats during the period of organogenesis. doses ≥4 mg/kg/day (at total maternal exposures <0.1% of total human exposures at the maximum recommended human dose based on auc) produced embryo-fetal death, major blood vessel malformations and other vascular anomalies, limb malformations (ectrodactyly, absent or misshapen long bones), an increased incidence of skeletal anomalies in multiple bones (vertebrae, sternebrae, ribs), and decreased fetal weight. risk summary there are no data on the presence of erdafitinib in human milk, or the effects of erdafitinib on the breastfed child, or on milk production. because of the potential for serious adverse reactions from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with balversa and for one month following the last dose. balversa can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating treatment with balversa. contraception females advise females of reproductive potential to use effective contraception during treatment with balversa and for one month after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during treatment with balversa and for one month after the last dose. infertility females based on findings from animal studies, balversa may impair fertility in females of reproductive potential [see nonclinical toxicology (13.1)] . safety and effectiveness of balversa in pediatric patients have not been established. in 4 and 13-week repeat-dose toxicology studies in rats and dogs, toxicities in bone and teeth were observed at an exposure less than the human exposure (auc) at the maximum recommended human dose. chondroid dysplasia/metaplasia were reported in multiple bones in both species, and tooth abnormalities included abnormal/irregular denting in rats and dogs and discoloration and degeneration of odontoblasts in rats. of the 479 patients treated with balversa in clinical studies, 40% of patients were less than 65 years old, 40% of patients were 65 years to 74 years old, and 20% were 75 years old and over. patients 65 years of age and older treated with balversa experienced a higher incidence of adverse reactions requiring treatment discontinuation than younger patients. in clinical trials, the incidence of treatment discontinuations of balversa due to adverse reactions was 10% in patients younger than 65 years, 20% in patients ages 65–74 years, and 35% in patients 75 years or older. no overall difference in efficacy was observed between these patients and younger patients [see clinical studies (14.1)]. cyp2c9*3/*3 genotype: erdafitinib plasma concentrations are predicted to be higher in patients with the cyp2c9*3/*3 genotype. monitor for increased adverse reactions in patients who are known or suspected to have cyp2c9*3/*3 genotype [see pharmacogenomics (12.5)] .

Singapore - engelska - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - pembrolizumab - infusion, solution concentrate - pembrolizumab 25.0 mg/ml

Kanada - engelska - Health Canada

seagen inc. - enfortumab vedotin - powder for solution - 20mg - enfortumab vedotin 20mg - antineoplastic agents

Kanada - engelska - Health Canada

seagen inc. - enfortumab vedotin - powder for solution - 30mg - enfortumab vedotin 30mg - antineoplastic agents

Singapore - engelska - HSA (Health Sciences Authority)

astellas pharma singapore pte. ltd. - enfortumab vedotin - injection, powder, lyophilized, for solution - enfortumab vedotin 20.0 mg/vial