Malesia - Kiingereza - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - latanoprost -

Malta - Kiingereza - Malta Medicines Authority

om pharma s.a. r. da industria, 2, 2610-088 amadora, lisboa, portugal - calcium dobesilate, dexamethasone acetate, lidocaine hydrochloride - ointment - calcium dobesilate 4 g dexamethasone acetate 0.025 g lidocaine hydrochloride 2 g - vasoprotectives

Singapoo - Kiingereza - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the carpentiers-edwards perimount pericardial bioprostheses is intended for use in the patients whose aortic or mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with prosthetic one. it is also intended for use in patients with a previously implanted aortic valve prosthesis which is no longer functioning adequately and requires replacement. in the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.

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

edwards lifesciences pty ltd - 60350 - aortic heart valve bioprosthesis/synthetic polymer aorta graft - intended for use as a replacement for the aortic heart valve and the ascending aorta. is indicated for patients who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

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

medtronic australasia pty ltd - 60247 - pulmonary transcatheter heart valve bioprosthesis - the tpv consists of a heterologous (bovine) jugular vein valve sutured within a laser-welded, platinum-iridium stent with gold brazing of the welds. the tpv is available in a 16 mm & 18mm bovine jugular vein (nominal length of 30 mm & 28mm). the ds consists of a balloon-in-balloon catheter with a retractable polytetrafluoroethylene (ptfe) sheath large enough to cover the tpv after crimping. the melody tpv is intended to be used in conjunction with the ensemble ii delivery system to restore and maintain pulmonary valve competence in a dysfunctional, surgically placed pulmonary conduit or bioprosthesis using percutaneous implantation techniques. the melody tpv system is indicated for use in patients with one of the following clinical conditions: ? patients with regurgitant prosthetic right ventricular outflow tract (rvot) conduits or bioprostheses with a clinical indication for invasive or surgical intervention ? patients with stenotic prosthetic rvot conduits or bioprostheses where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting

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

edwards lifesciences pty ltd - 60244 - mitral heart valve bioprosthesis - the device is a trileaflet stent-supported bioprosthetic valve comprised of bovine pericardium mounted on a flexible frame. it is designed to be compliant at the orifice and commissures to reduce the closing loading shocks at the commissure tips and free margin of the leaflets. an elgiloy band surrounds the base of the wireform frame providing structural support for the orifice and identification radiologically. the carpentier-edwards perimount plus pericardial bioprosthesis model6900ptfx mitral is indicated for patients who require replacement of their native or prosthetic mitral valve. the device is mr conditional under 3t.

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

abbott medical australia pty ltd - 60242 - aortic heart valve bioprosthesis - the tri-leaflet stented pericardial valve is designed for supra-annular placement in the aortic position. the valve is fabricated using a polyester-covered titanium stent. the stent and a titanium band within the sewing cuff provide radiopacity for visualisation of the valve. the valve is intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve. the valve may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

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

abbott medical australia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the portico valve is a pericardial, tri-leaflet valve, mounted inside a self-expanding stent designed for intra-annular placement using minimally invasive techniques. the valve is designed to be implanted in the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve. the portico valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are considered high surgical risk. the portico transcatheter delivery system is indicated for transfemoral or subclavian/axillary delivery of the portico valve. the portico transfemoral/alternative access loading system is indicated for loading the portico valve in the portico transcatheter delivery system.