European Union - English - EMA (European Medicines Agency)

xbiotech germany gmbh - human igg1 monoclonal antibody specific for human interleukin-1 alpha - colorectal neoplasms - antineoplastic agents - treatment of metastatic colorectal cancer

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - human papillomavirus (hpv) 11 l1 protein 40ug;  ; human papillomavirus (hpv) 16 l1 protein 60ug;  ; human papillomavirus (hpv) 18 l1 protein 40ug;  ; human papillomavirus (hpv) 31 l1 protein 20ug;  ; human papillomavirus (hpv) 33 l1 protein 20ug;  ; human papillomavirus (hpv) 45 l1 protein 20ug;  ; human papillomavirus (hpv) 52 l1 protein 20ug;  ; human papillomavirus (hpv) 58 l1 protein 20ug;  ; human papillomavirus (hpv) 6 l1 protein 30ug;   - suspension for injection - 0.5 ml - active: human papillomavirus (hpv) 11 l1 protein 40ug   human papillomavirus (hpv) 16 l1 protein 60ug   human papillomavirus (hpv) 18 l1 protein 40ug   human papillomavirus (hpv) 31 l1 protein 20ug   human papillomavirus (hpv) 33 l1 protein 20ug   human papillomavirus (hpv) 45 l1 protein 20ug   human papillomavirus (hpv) 52 l1 protein 20ug   human papillomavirus (hpv) 58 l1 protein 20ug   human papillomavirus (hpv) 6 l1 protein 30ug   excipient: aluminium as amorphous aluminium hydroxyphosphate sulfate adjuvant histidine polysorbate 80 sodium borate sodium chloride water for injection - gardasil 9 is indicated in females aged 9 through 45 years for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine). gardasil 9 is indicated in males 9 through 45 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by hpv types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).

Kenya - English - Pharmacy and Poisons Board

human bioplazma llc h-2100 godollo transics milhaly ut 80hungary - human albumin - solution for infusion - 20%human albumin - blood substitutes and plasma protein fractions

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

ge healthcare inc. - human albumin microspheres (unii: t8c6w1n6nw) (human albumin microspheres - unii:t8c6w1n6nw), perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - human albumin microspheres 10 mg in 1 ml - optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. do not administer optison to patients with known or suspected hypersensitivity to perflutren or albumin [see warnings and precautions (5.5)] . risk summary there are no data with optison use in pregnant women to inform any drug-associated risks. no adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of optison to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area (see data ). 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 optison was administered intravenously to rats at doses of 0.25, 5 and 10 ml/kg/day (approximately 0.2, 5 and 10 times the recommended maximum human dose of 8.7 ml, respectively, based on body surface area) and to rabbits at 0.25, 2.5 and 5 ml/kg/day (approximately 0.5, 5 and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. no significant findings attributable solely to a direct effect on the fetus were detected in the studies. there are no data on the presence of perflutren protein-type a microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for optison and any potential adverse effects on the breastfed infant from optison or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of subjects in a clinical study of optison, 35% were 65 and over, while 14% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

European Union - English - EMA (European Medicines Agency)

takeda manufacturing austria ag - human protein c - purpura fulminans; protein c deficiency - antithrombotic agents - ceprotin is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein c deficiency.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - human papillomavirus (hpv) 16 l1 protein 20ug;  ; human papillomavirus (hpv) 18 l1 protein 20ug;   - suspension for injection - active: human papillomavirus (hpv) 16 l1 protein 20ug   human papillomavirus (hpv) 18 l1 protein 20ug   excipient: aluminium hydroxide monobasic sodium phosphate monohydrate monophosphoryl lipid a sodium chloride water for injection - cervarix is indicated in females from 10 to 45 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by oncogenic human papillomavirus (hpv).

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - plasma protein containing at least 95% human albumin - solution for infusion - 50 gram(s)/litre - blood substitutes and plasma protein fractions; albumin - plasma substitutes and plasma protein fractions - restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - plasma protein containing at least 95% human albumin - solution for infusion - 200 gram(s)/litre - blood substitutes and plasma protein fractions; albumin - plasma substitutes and plasma protein fractions - restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate

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

grifols usa, llc - .alpha.1-proteinase inhibitor human (unii: f43i396ois) (.alpha.1-proteinase inhibitor human - unii:f43i396ois) - .alpha.1-proteinase inhibitor human 1000 mg in 20 ml - prolastin-c is an alpha1 -proteinase inhibitor (human) (alpha1 -pi) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1 -pi (alpha1 -antitrypsin deficiency). prolastin-c increases antigenic and functional (anti-neutrophil elastase capacity, anec) serum levels and antigenic lung epithelial lining fluid levels of alpha1 -pi. limitations of use - the effect of augmentation therapy with any alpha1 -pi, including prolastin-c, on pulmonary exacerbations and on the progression of emphysema in alpha1 -pi deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. - clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with prolastin-c are not available. - prolastin-c is not indicated as therapy for lung disease in patients in whom severe alpha1 -pi deficiency has not been established. prolastin-c is contraindicated in: - iga deficient patients w

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

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.