South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

kahma biotech (pty) ltd - suspension - see ingredients - each vial contains mycobacterium bovis 30,0 mg

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bec biotech pty ltd - megasphaera elsdenii - oral solution/suspension - megasphaera elsdenii enzyme active 1.0e8 cfu/ml - nutrition & metabolism

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

kahma biotech (pty) ltd - infusion - see ingredients - each vial contains ertapenem sodium equivalent to ertapenem 1,0 g

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

haemologic biotech pty ltd - 44904 - blood/tissue storage/culture container - intended to be used in conjunction with apheresis equipment for the collection and storage of plasma and/or blood components

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

genesis biotech pty ltd - ct944 - software ivds - healthcare software app and cloud software platform developed for use with healthcare devices including blood glucose meter. the software is intended to transfer, store and share patient data collected from the healthcare devices

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

haemologic biotech pty ltd - 58977 - basic intravenous administration set - an administration set used as part or all of a delivery system to deliver intravenous solutions to the infusion site. it may have a variety of connections, chambers, clamps, length, needles or injection ports. it is typically used for gravitational intravenous administration other than with an infusion using a pump.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bec biotech pty ltd - megasphaera elsdenii - oral solution/suspension - megasphaera elsdenii enzyme active 1000.0 g/l - nutrition & metabolism

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

genesis biotech pty ltd - ct287 - clinical chemistry ivds - ivds that are intended to be used for the testing of blood glucose in a clinical specimen

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

genesis biotech pty ltd - 12719 - nebulizer, ultrasonic - portable nebulizer intended to be used to provide aerosolized medication for a patient to inhale for respiratory disorders

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

well biotech pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - intended to detect the novel coronavirus sars-cov-2 that causes covid-19. for self-testing by lay persons (saliva).