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

stryker australia pty ltd - 47635 - craniofacial bone distractor - intended to be used for bone stabilization and lengthening of the mandibular body and ramus in neonates and children up to 4 years old.

Canada - English - Health Canada

sandoz canada incorporated - digoxin - liquid - 0.05mg - digoxin 0.05mg - cardiotonic agents

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

medtronic australasia pty ltd - 47799 - cardioplegia cannula - pediatric aortic root cannula with ribs for use in cardiopulmonary bypass procedure this cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. the cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

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

medtronic australasia pty ltd - 47799 - cardioplegia cannula - pediatric aortic root cannula for use in cardiopulmonary bypass procedure with white standard tip this cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. the cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

kck pharmaceutical industries sdn. bhd. - diphenhydramine hydrochloride; levomenthol; ammonium chloride -

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

teleflex medical australia pty ltd - 61594 - central venous catheterization kit, short-term - the set consists of a multi-lumen indwelling catheter along with ancillary components to assist in insertion. the catheter consists of polyurethane with blue flextip?, with an exterior antimicrobial surface treatment, leur lock connections and centimetre markings. a collection of sterile devices and materials intended to provide short-term introduction of a paediatric central venous catheter for treatment of diseases or procedures requiring central venous access. the arrowg+ard antimicrobial surface is intended to provide protection against catheter-related bloodstream infections. it may be inserted into the jugular, subclavian, or femoral veins. the device is intended for paediatric use.

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

medtronic australasia pty ltd - 34905 - cannula, venous - pediatric cannula and introducers. sterile, nonpyrogenic, disposable single-use only. cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. the cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the venous vessel for cardiopulmonary bypass.

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

medtronic australasia pty ltd - 34893 - cannula, arterial - pediatric cannula and introducers. sterile, nonpyrogenic, disposable single-use only. cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. the cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass.

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

getinge australia pty ltd - 17643 - oxygenator, extracorporeal membrane - the quadrox-id pediatric oxygenator oxygenates the blood, removes carbon dioxide and regulates the blood temperature. the quadrox-id peadiatric oxygenator is intended for extracorporeal pulmonary support and cardiovascular support.

Israel - English - Ministry of Health

sanofi israel ltd - hepatitis a vaccines - suspension for injection - hepatitis a vaccines 80 units / 0.5 ml - hepatitis a, inactivated, whole virus - hepatitis a, inactivated, whole virus - avaxim 80 u pediatric is indicated for active immunisation against infection caused by hepatitis a virus in children aged from 12 months to 15 years inclusive, who are at risk either of contaminating or spreading infection or of a life threatening disease if infected.