Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - vortioxetine hydrobromide - film-coated tablet - vortioxetine

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - vortioxetine hydrobromide - film-coated tablet - vortioxetine

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - vortioxetine hydrobromide - film-coated tablet - vortioxetine

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - vortioxetine hydrobromide - film-coated tablet - vortioxetine

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

takeda pharmaceuticals america, inc. - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - vortioxetine 5 mg - brintellix is indicated for the treatment of major depressive disorder (mdd). the efficacy of brintellix was established in six 6 to 8 week studies (including one study in the elderly) and one maintenance study in adults [see clinical studies (14)] . pregnancy category c risk summary there are no adequate and well-controlled studies of brintellix in pregnant women. vortioxetine caused developmental delays when administered during pregnancy to rats and rabbits at doses 15 and 10 times the maximum recommended human dose (mrhd) of 20 mg, respectively. developmental delays were also seen after birth in rats at doses 20 times the mrhd of vortioxetine given during pregnancy and through lactation. there were no teratogenic effects in rats or rabbits at doses up to 77 and 58 times, the mrhd of vortioxetine, respectively, given during organogenesis. the incidence of malformations in human pregnancies has not been established for brintellix. all human pregnancies, regardless of drug exposure, have a background rate of

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

lundbeck australia pty ltd - vortioxetine hydrobromide, quantity: 6.355 mg (equivalent: vortioxetine, qty 5 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; hyprolose; sodium starch glycollate type a; mannitol; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - treatment of major depressive disorder in adults including prevention of relapse. vortioxetine is not indicated for paediatric use.

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

lundbeck australia pty ltd - vortioxetine hydrobromide, quantity: 19.065 mg (equivalent: vortioxetine, qty 15 mg) - tablet, film coated - excipient ingredients: magnesium stearate; mannitol; sodium starch glycollate type a; hyprolose; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400 - treatment of major depressive disorder in adults including prevention of relapse. vortioxetine is not indicated for paediatric use.

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

lundbeck australia pty ltd - vortioxetine hydrobromide, quantity: 25.42 mg (equivalent: vortioxetine, qty 20 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; hyprolose; microcrystalline cellulose; mannitol; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - treatment of major depressive disorder in adults including prevention of relapse. vortioxetine is not indicated for paediatric use.

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

lundbeck australia pty ltd - vortioxetine hydrobromide, quantity: 12.71 mg (equivalent: vortioxetine, qty 10 mg) - tablet, film coated - excipient ingredients: mannitol; hyprolose; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - treatment of major depressive disorder in adults including prevention of relapse. vortioxetine is not indicated for paediatric use.

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

takeda pharmaceuticals america, inc. - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - vortioxetine 5 mg - trintellix is indicated for the treatment of major depressive disorder (mdd) in adults. - hypersensitivity to vortioxetine or any component of the formulation. hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with trintellix [see adverse reactions (6.2)] . - the use of maois intended to treat psychiatric disorders with trintellix or within 21 days of stopping treatment with trintellix is contraindicated because of an increased risk of serotonin syndrome. the use of trintellix within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.4), warnings and precautions (5.2)] . starting trintellix in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monit