Szingapúr - angol - HSA (Health Sciences Authority)

livanova singapore pte. ltd. - cardiovascular - the mitroflow valsalva conduit is a vascular conduit designed to be coupled with the mitroflow or crown prt valve directly in the operating room, in open heart surgery, for simultaneous replacement of the ascending aorta and the aortic valve in cases of aneurysm, dissection, or other disease conditions of the aorta combined with disease or degeneration of the aortic valve.

Szingapúr - angol - HSA (Health Sciences Authority)

livanova singapore pte. ltd. - cardiovascular - the mitroflow valve is intended for the replacement of malfunctioning native or prosthetic aortic valves. the mitroflow valve is suggested for use in those patients where long-term anticoagulation therapy may be undesirable for a variety of reasons, such as patients living in remote areas, patients with gastrointestinal or other bleeding problems, patients who may be expected to undergo other surgery, elderly patients and others where difficulty may be expected with anticoagulants, for social, or other medical reasons.

Szingapúr - angol - HSA (Health Sciences Authority)

livanova singapore pte ltd - cardiovascular - the stockert centrifugal pump (scp) system is intended for use as a centrifugal pump during cardiovascular bypass for typical durations of six hours or less. the system has been developed for operation with the stockert heart-lung machines and/or the scpc system. the scp system consists of the pump control panel, the drive unit, the flow probe and the cobe(r) revolution cbp. the system will be used or incorporated with the tubing clamp, emergency unit and scp.the scp has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ecmo) procedures.

Szingapúr - angol - HSA (Health Sciences Authority)

livanova singapore pte ltd - cardiovascular - the storkert centrifugal pump console (scpc system) is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (ups) and s3 sensor modules that is designed for operation of the stockert centrifugal pump (scp) and monitoring the cardiopulmonary bypass circuit. the spcp system, in combination with the scp and the cobe revolution pump head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. the scpc system has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ecmo) procedures.

Szingapúr - angol - HSA (Health Sciences Authority)

livanova singapore pte ltd - hematology - indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection).

Szingapúr - angol - HSA (Health Sciences Authority)

livanova singapore pte ltd - neurology - the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications. aspiresr® feature the automatic stimulation mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia.

Szingapúr - angol - HSA (Health Sciences Authority)

livanova singapore pte ltd - neurology - the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures(with or without secondary generalization) or generalized seizures that are refractory to seizure medications.

Izrael - angol - Ministry of Health

abic marketing ltd, israel - fremanezumab - solution for injection - fremanezumab 225 mg / 1.5 ml - ajovy is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - metformin hydrochloride, quantity: 500 mg; glibenclamide, quantity: 5 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; quinoline yellow; iron oxide yellow; iron oxide red; macrogol 4000 - second line treatment of diabetes mellitus type ii in adult patients whose glycaemic control is inadequate after diet and exercise alone and where combined therapy with metformin and glibenclamide is appropriate.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - metformin hydrochloride, quantity: 500 mg; glibenclamide, quantity: 2.5 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000; iron oxide black - second line treatment of diabetes mellitus type ii in adult patients whose glycaemic control is inadequate after diet and exercise alone and where combined therapy with metformin and glibenclamide is appropriate.