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

microport crm pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - the device is a semi-compliant percutaneous transluminal coronary angioplasty (ptca) rapid exchange system that consists of an integrated shaft and a balloon at the distal end of the catheter. the proximal end of the catheter has a standard luer to inflate or deflate the balloon by contrast medium. the coaxial dual lumen distal shaft creates the rapid exchange capability. the balloon catheter is coated with hydrophilic coating. firefighter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

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

demax medical australia pty ltd - 17184 - catheter, angioplasty, balloon dilatation - this product is indicated for percutaneous transluminal angioplasty (pta) in patients with peripheral arterial obstructive disease, so as to improve the blood supply capacity of the blood vessel.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - bivalirudin 100mg - powder for injection - 100 mg - active: bivalirudin 100mg excipient: mannitol sodium hydroxide - angiomax is indicated for use as an anticoagulant: · in the treatment of patients with moderate to high risk acute coronary syndromes (acs) (unstable angina/non-st segment elevation myocardial infarction (ua/nstemi) who are undergoing early invasive management, and · in patients undergoing percutaneous coronary intervention (pci). angiomax is intended for use with aspirin. a p2y12 antagonist (eg clopidogrel or ticlopidine) may be used in addition to aspirin.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - bivalirudin 250mg - powder for injection - 250 mg - active: bivalirudin 250mg excipient: mannitol sodium hydroxide - angiomax is indicated for use as an anticoagulant: · in the treatment of patients with moderate to high risk acute coronary syndromes (acs) (unstable angina/non-st segment elevation myocardial infarction (ua/nstemi) who are undergoing early invasive management, and · in patients undergoing percutaneous coronary intervention (pci). angiomax is intended for use with aspirin. a p2y12 antagonist (eg clopidogrel or ticlopidine) may be used in addition to aspirin.

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - influenza virus (nh) a/darwin/9/2021 (h3n2) - like strain ( a/darwin/9/2021, ivr-228); influenza virus (nh) a/victoria/4897/2022 (h1n1)pdm09-like strain (a/victoria/4897/2022, ivr-238); influenza virus (nh) b/austria/1359417/2021 - like strain(b/michigan/01/2021, wild type); influenza virus (nh) b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type); influenza virus (sh) a/thailand/8/2022 (h3n2) - like strain ( a/california/122/2022, san-022); influenza virus (sh) a/victoria/4897/2022 (h1n1)pdm09-like strain (a/victoria/4897/2022, ivr-238); influenza virus (sh) b/austria/1359417/2021 - like strain(b/michigan/01/2021, wild type); influenza virus (sh) b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type) - injection, suspension - influenza virus (nh) a/darwin/9/2021 (h3n2) - like strain ( a/darwin/9/2021, ivr-228) 15 mcg/0.5 ml; influenza virus (nh) a/victoria/4897/2022 (h1n1)pdm09-like strain (a/victoria/4897/2022, ivr-238) 15 mcg/0.5 ml; influenza virus (nh) b/austria/1359417/2021 - like strain(b/michigan/01/2021, wild type) 15 mcg/0.5 ml; influenza virus (nh) b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type) 15 mcg/0.5 ml; influenza virus (sh) a/thailand/8/2022 (h3n2) - like strain ( a/california/122/2022, san-022) 15 mcg/0.5 ml; influenza virus (sh) a/victoria/4897/2022 (h1n1)pdm09-like strain (a/victoria/4897/2022, ivr-238) 15 mcg/0.5 ml; influenza virus (sh) b/austria/1359417/2021 - like strain(b/michigan/01/2021, wild type) 15 mcg/0.5 ml; influenza virus (sh) b/phuket/3073/2013 - like strain (b/phuket/3073/2013, wild type) 15 mcg/0.5 ml

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

emergo asia pacific pty ltd t/a emergo australia - 37291 - angiography contrast medium injection system, battery-powered - the injector systems are intended exclusively for the injection of contrast media and/or physiological saline solution into patients for examinations involving angiography, neuroradiology, intervention and computed tomography by trained and authorised staff. they are supplied with a remote control to allow for operation of the injector from the control room.

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

emergo asia pacific pty ltd t/a emergo australia - 37291 - angiography contrast medium injection system, battery-powered - the injector system is intended exclusively for the injection of contrast media into patients for examinations involving angiography, neuroradiology and computed tomography by trained and authorised staff. it is supplied with a remote control to allow for operation of the injector from the control room.

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

emergo asia pacific pty ltd t/a emergo australia - 57998 - angiography contrast medium injection system, line-powered, stationary - the injector system is intended exclusively for the injection of contrast medium into patients for examinations involving angiography, neuroradiology, and computed tomography by trained and authorised staff. it is supplied with a remote control to allow for operation of the injector from the control room.

Singapore - English - HSA (Health Sciences Authority)

angeion medical international pte. ltd. - cardiovascular - the abluminus sirolimus eluting coronary stent system is indicated for improving luminal diameter in patients, including those with diabetes mellitus, acute myocardial infarction, symptomatic heart disease, stable angina, unstable angina or documented silent ischemia due to atherosclerotic lesions in native coronary arteries with reference diameter 2.25mm to 5.00mm and lesions of length ≤48 mm.

Singapore - English - HSA (Health Sciences Authority)

angeion medical international pte. ltd. - radiology / imaging - the ready-box contrast media warmer is intended to warm contrast media to approximately body temperature before injection.