Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 60242 - aortic heart valve bioprosthesis - the intended purpose of the avalus ultra bioprosthesis is to restore unidirectional blood flow through the aortic annulus by replacing a diseased or damaged heart valve. the accessories facilitate the implantation of the avalus ultra bioprosthesis.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. it includes 3 gold radiopaque markers and are manufactured by suturing valve leaflets and an inner skirt from porcine pericardium into a tri-leaflet configuration. the bioprosthesis has a porcine pericardial tissue outer skirt (wrap), which is 1.5 cells in height and is sutured to the inflow section of the bioprosthesis. the evolut fx system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. the evolut fx system is also indicated for patients with a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are at high or greater risk for surgical aortic valve replacement (avr) where high risk is defined as society of thoracic surgeons operative risk score ?8% or documented heart team agreement of risk for avr due to frailty or comorbidities.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

corcym pty ltd - 60242 - aortic heart valve bioprosthesis - perceval plus is a bioprosthetic valve with the unique characteristic of allowing sutureless positioning and anchoring at the implant site. prior to implantation the prosthesis diameter is reduced to a suitable size for loading it on the holder. the valve is then positioned and released in the aortic root, where the stent design and its ability to apply a radial force to the annulus allows stable anchoring of the device perceval plus prosthesis is intended to replace a damaged native aortic heart valve or a malfunctioning aortic prosthesis via open heart surgery. it is is indicated for use in adult patients: - suffering from aortic valve stenosis or steno-insufficiency; - with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement

Tanżanija - Ingliż - Tanzania Medicinces & Medical Devices Authority

fdc limited, india - latanoprost - eye drops - 50 mcg + 5 mg

Namibja - Ingliż - Namibia Medicines Regulatory Council

fdc limited - latanoprost+timolol - drops - each ml contains latanoprost 50mcg and timolol maleate 5mg

Malta - Ingliż - Medicines Authority

laboratorio chimico farmaceutico a. sella s.r.l. via vicenza 67 - 36015 schio (vi), italy - lidocaine hydrochloride, hydrocortisone acetate - cream - lidocaine hydrochloride 1.5 g hydrocortisone acetate 1 g - vasoprotectives

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

schering (nz) limited - chlorquinaldol 10 mg/g; fluocortolone pivalate 1 mg/g; lidocaine hydrochloride monohydrate 20 mg/g - topical cream - 10mg,1mg,20mg/g - active: chlorquinaldol 10 mg/g fluocortolone pivalate 1 mg/g lidocaine hydrochloride monohydrate 20 mg/g

Filippini - Ingliż - FDA (Food And Drug Administration)

bayer philippines, inc. - flucortolone pivalate , lidocaine hydrochloride - cream - 1mg + 20mg perg

Malta - Ingliż - Medicines Authority

neofarma pharmaceuticals limited 42-46, mill street, qormi, qrm 3105, malta - fluocortolone pivalate, lidocaine hydrochloride - rectal cream - fluocortolone pivalate 1 mg/g lidocaine hydrochloride 20 mg/g - vasoprotectives