Canada - English - Health Canada

glaxosmithkline inc - colfosceril palmitate - powder for suspension - 108mg - colfosceril palmitate 108mg - miscellaneous therapeutic agents

Canada - English - Health Canada

glaxosmithkline inc - colfosceril palmitate - powder for suspension - 108mg - colfosceril palmitate 108mg - miscellaneous therapeutic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - colfosceril palmitate 108mg - powder for intratracheal suspension - 108 mg - active: colfosceril palmitate 108mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - colfosceril palmitate - powder for suspension for endotracheopulmonary instillation - 67.5mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - colfosceril palmitate - powder for suspension for endotracheopulmonary instillation - 108mg

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - bovine lung lipids 25 mg/ml (total phospholipids); colfosceril palmitate 11 mg/ml - 15.5 mg/ml (disaturated phosphatidylcholine); palmitic acid 1.4 mg/ml - 3.5 mg/ml (free fatty acid); tripalmitin 0.5 mg/ml - 1.75 mg/ml (triglycerides) - intratracheal suspension - 25 mg/ml - active: bovine lung lipids 25 mg/ml (total phospholipids) colfosceril palmitate 11 mg/ml - 15.5 mg/ml (disaturated phosphatidylcholine) palmitic acid 1.4 mg/ml - 3.5 mg/ml (free fatty acid) tripalmitin 0.5 mg/ml - 1.75 mg/ml (triglycerides) excipient: sodium chloride water for injection - survanta is indicated for prevention and treatment ("rescue") of respiratory distress syndrome (rds) (hyaline membrane disease) in premature infants. survanta significantly reduces the incidence of rds, mortality due to rds and air leak complications.

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

abbvie pty ltd - beractant, quantity: 25 mg/ml - suspension - excipient ingredients: colfosceril palmitate; tripalmitin; palmitic acid; sodium chloride; phosphatidyl choline; water for injections - prevention and treatment ("rescue") of respiratory distress syndrome (rds) (hyaline membrane disease) in premature infants.

Ireland - English - HPRA (Health Products Regulatory Authority)

wellcome (ireland) limited - colfosceril palmitate - pdr+solv/susp/epulminst - 13.5 mg/ml

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

abbvie pty ltd - beractant -

New Zealand - English - Medsafe (Medicines Safety Authority)

global medical solutions (nz) limited - perflutren 1.1 mg/ml - solution for injection - 1.1 mg/ml - active: perflutren 1.1 mg/ml excipient: colfosceril palmitate dibasic sodium phosphate monohydrate glycerol sodium dipalmitoylphosphatidate n-(methoxy-peg-5000 carbamoyl)-dipalmitoylphosphatidylethanolamine sodium monobasic sodium phosphate monohydrate propylene glycol sodium chloride water for injection