Kanada - angličtina - Health Canada

novartis pharmaceuticals canada inc - ofatumumab - solution - 1000mg - ofatumumab 1000mg - antineoplastic agents

Švýcarsko - němčina - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - ofatumumabum - injektionslösung in fertigspritze - ofatumumabum 20 mg, argininum, natrii acetas trihydricus, natrii chloridum, polysorbatum 80, dinatrii edetas, acidum hydrochloridum 25 per centum, aqua ad iniectabile q.s. ad solutionem pro 0.4 ml corresp. natrium 0.92 mg. - multiple sklerose - biotechnologika

Švýcarsko - němčina - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - ofatumumabum - injektionslösung in fertigpen - ofatumumabum 20 mg, argininum, natrii acetas trihydricus, natrii chloridum, polysorbatum 80, dinatrii edetas, acidum hydrochloridum 25 per centum, aqua ad iniectabile q.s. ad solutionem pro 0.4 ml corresp. natrium 0.92 mg. - multiple sklerose - biotechnologika

Švýcarsko - francouzština - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - ofatumumabum - solution injectable en seringue préremplie - ofatumumabum 20 mg, argininum, natrii acetas trihydricus, natrii chloridum, polysorbatum 80, dinatrii edetas, acidum hydrochloridum 25 per centum, aqua ad iniectabile q.s. ad solutionem pro 0.4 ml corresp. natrium 0.92 mg. - multiple sklerose - biotechnologika

Švýcarsko - francouzština - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - ofatumumabum - solution injectable en stylo prérempli - ofatumumabum 20 mg, argininum, natrii acetas trihydricus, natrii chloridum, polysorbatum 80, dinatrii edetas, acidum hydrochloridum 25 per centum, aqua ad iniectabile q.s. ad solutionem pro 0.4 ml corresp. natrium 0.92 mg. - multiple sklerose - biotechnologika

Izrael - angličtina - Ministry of Health

novartis israel ltd - ofatumumab - solution for injection - ofatumumab 50 mg/ml - ofatumumab - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features

Spojené státy - angličtina - NLM (National Library of Medicine)

janssen biotech, inc. - daratumumab (unii: 4z63yk6e0e) (daratumumab - unii:4z63yk6e0e), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - darzalex faspro is indicated for the treatment of adult patients with multiple myeloma: - in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. - in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. - in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. - in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. - in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. - in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have receive

Peru - španělština - DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

johnson & johnson del peru s.a. - daratumumab - concentrado para solución para perfusión - 20 mg/ml - por ; daratumumab 20.000000 mg; - daratumumab

Izrael - hebrejština - Ministry of Health

j-c health care ltd - daratumumab - תרכיז להכנת תמיסה לאינפוזיה - daratumumab 20 mg / 1 ml - daratumumab

Spojené státy - angličtina - NLM (National Library of Medicine)

genentech, inc. - polatuzumab vedotin (unii: kg6vo684z6) (polatuzumab vedotin - unii:kg6vo684z6) - polivy in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients who have previously untreated diffuse large b-cell lymphoma (dlbcl), not otherwise specified (nos) or high-grade b-cell lymphoma (hgbl) and who have an international prognostic index score of 2 or greater. polivy in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory dlbcl, nos, after at least two prior therapies. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , polivy can cause fetal harm. there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of the small molecule component of polivy, mmae, to pregnant rats during organogenesis at exposures below the clinical exposure at the recommended dose of 1.8 mg/kg polivy every 21 days resulted in embryo-fetal mortality and structural abnormalities (see data) . advise a pregnant woman of the potential risks to a 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 no embryo-fetal development studies in animals have been performed with polatuzumab vedotin-piiq. in an embryo-fetal developmental study in pregnant rats, administration of two intravenous doses of mmae, the small molecule component of polivy, on gestational days 6 and 13 caused embryo-fetal mortality and structural abnormalities, including protruding tongue, malrotated limbs, gastroschisis, and agnathia compared to controls at a dose of 0.2 mg/kg (approximately 0.5-fold the human area under the curve [auc] at the recommended dose). risk summary there is no information regarding the presence of polatuzumab vedotin-piiq in human milk, the effects on the breastfed child, or milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with polivy and for 2 months after the last dose. polivy can cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating polivy [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during treatment with polivy and for 3 months after the last dose [see nonclinical toxicology (13.1)] . males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with polivy and for 5 months after the final dose [see nonclinical toxicity (13.1)] . infertility females based on findings in animal studies with mmae-containing antibody-drug conjugates (adcs), polivy may impair female fertility. the effect on fertility is reversible [see nonclinical toxicology (13.1)] . males based on findings from animal studies, polivy may impair male fertility. the reversibility of this effect is unknown [see nonclinical toxicology (13.1)] . safety and effectiveness of polivy have not been established in pediatric patients. among 435 patients treated with polivy plus r-chp in polarix, 227 (52%) were ≥65 years of age. no overall differences in safety or efficacy were observed between patients aged ≥65 years and younger patients. among 173 patients treated with polivy plus br in study go29365, 95 (55%) were ≥65 years of age. patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) than patients aged <65 (53%). this study did not include sufficient numbers of patients to determine whether efficacy differed in patients aged ≥65 and younger patients. avoid the administration of polivy in patients with moderate or severe hepatic impairment (total bilirubin greater than 1.5 × uln and any ast). patients with moderate or severe hepatic impairment are likely to have increased exposure to mmae, which may increase the risk of adverse reactions. polivy has not been studied in patients with moderate or severe hepatic impairment [see clinical pharmacology (12.3) and warnings and precautions (5.7)]. no adjustment in the starting dose is required when administering polivy to patients with mild hepatic impairment (total bilirubin 1 to 1.5 × uln or ast greater than uln).