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

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the evolut pro system is a recapturable transcatheter aortic valve replacement system, which includes the corevalve evolut pro transcatheter aortic valve, the enveo r delivery catheter system,and the enveo r loading system. the support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. the bioprosthesis is manufactured by suturing valve leaflets and an inner skirt from porcine pericardium into a tri-leaflet configuration. the corevalve evolut pro 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 corevalve evolut pro 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.

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

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the medtronic corevalve? evolut? r system is a recapturable transcatheter aortic valve implantation system, which includes the corevalve? evolut? r transcatheter aortic valve, the enveo? r delivery catheter system, and the enveo? r loading system. the support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. the bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration. the corevalve evolut r 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 corevalve evolut r 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.

Singapore - English - HSA (Health Sciences Authority)

medtronic international, ltd. - cardiovascular - indicated for patients with severe symptomatic native aortic valve stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., society of thoracic surgeons predicted risk of operative mortality score ≥8% or at a ≥15% risk of mortality at 30 days). for patients presenting with severe native bicuspid aortic valve stenosis, corevalve evolut r system is indicated for patients who are at intermediate or greater risk for surgical aortic valve replacement (avr) where intermediate risk is defined as society of thoracic surgeons operative risk score of ≥4% or documented heart team agreement of risk for avr due to frailty or comorbidities.

Singapore - English - HSA (Health Sciences Authority)

medtronic international, ltd. - cardiovascular - the medtronic corevalve™ system is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., society of thoracic surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).

Singapore - English - HSA (Health Sciences Authority)

medtronic international, ltd. - cardiovascular - indicated for patients with severe symptomatic native aortic valve stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy(i.e., society of thoracic surgeons predicted risk of operative mortality score ≥8% or at a ≥15% risk of mortality at 30 days). for patients presenting with severe native bicuspid aortic valve stenosis, corevalve evolut pro system is indicated for patients who are at intermediate or greater risk for surgical aortic valve replacement (avr) where intermediate risk is defined as society of thoracic surgeons operative risk score of ≥4% or documented heart team agreement of risk for avr due to frailty or comorbidities.

Singapore - English - HSA (Health Sciences Authority)

medtronic international, ltd. - cardiovascular - the medtronic corevalve™ system is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., society of thoracic surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).

India - English - Central Drugs Standard Control Organization

oreva darmo. - crm - 50g

India - English - Central Drugs Standard Control Organization

oreva darmo. - benzoyl peroxide - gel - 2.5% - 20g

India - English - Central Drugs Standard Control Organization

oreva darmo. - benzoyl peroxide - gel - 5% - 20g

India - English - Central Drugs Standard Control Organization

oreva darmo. - glycolic acid - lot - 8% - 100ml