Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

eli lilly and company - bamlanivimab (unii: 45i6ofj8qh) (bamlanivimab - unii:45i6ofj8qh) - treatment the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to permit the emergency use of the unapproved products bamlanivimab and etesevimab administered together for the treatment of mild to moderate coronavirus disease 2019 (covid-19) in adults and pediatric patients, including neonates, with positive results of direct sars-cov-2 viral testing, and who are at high risk for progression to severe covid-19, including hospitalization or death. limitations of authorized use - bamlanivimab and etesevimab are not authorized for treatment of mild to moderate covid-19 in geographic regions where infection is likely to have been caused by a non-susceptible sars-cov-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency. fda's determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#co

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

eli lilly and company - etesevimab (unii: n7q9nlf11i) (etesevimab - unii:n7q9nlf11i) - treatment the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to permit the emergency use of the unapproved products bamlanivimab and etesevimab administered together for the treatment of mild to moderate coronavirus disease 2019 (covid-19) in adults and pediatric patients, including neonates, with positive results of direct sars-cov-2 viral testing, and who are at high risk for progression to severe covid-19, including hospitalization or death. limitations of authorized use - bamlanivimab and etesevimab are not authorized for treatment of mild to moderate covid-19 in geographic regions where infection is likely to have been caused by a non-susceptible sars-cov-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency. fda's determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#co

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

glaxosmithkline llc - sotrovimab (unii: 1mtk0bpn8v) (sotrovimab - unii:1mtk0bpn8v) - the secretary of health and human services (hhs) has issued an emergency use authorization (eua) for the emergency use of sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (covid-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct sars-cov-2 viral testing, and who are at high risk for progression to severe covid-19, including hospitalization or death. however, sotrovimab is not approved for this use (i.e., sotrovimab has not been demonstrated to be safe and effective for this use). limitations of authorized use benefit of treatment with sotrovimab has not been observed in patients hospitalized due to covid‑19. sars-cov-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with covid‑19 requiring high flow oxygen or mechanical ventilation [see warnings and precautions (5.2)] . sotrovimab is not fda-approved for any use, including for the treatment of covid-19.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - cilgavimab (unii: 1kur4bn70f) (cilgavimab - unii:1kur4bn70f) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of the unapproved product evusheld (tixagevimab co-packaged with cilgavimab) for the pre-exposure prophylaxis of coronavirus disease 2019 (covid-19) in adults and pediatric individuals (12 years of age and older weighing at least 40 kg): evusheld may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which evusheld belongs (i.e., anti-infectives). evusheld has been authorized by fda for the emergency use described above. evusheld is not fda-approved for any use, including use for pre-exposure prophylaxis of covid-19. evusheld is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of evusheld under section 564(b)(1) of the act, 21 u.s.c. § 360bbb-3(b)(1), unless

Australija - anglų - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - ct936 - specimen receptacle ivds - intended use of the breathtracker collection receptacles is to collect and store breath to be analyzed to aid in the diagnosis of various gastrointestinal conditions.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - ct943 - instrument/analyser ivds - intended use of the breathtracker analyzer is to aid in the diagnosis of various gastrointestinal conditions.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 44759 - fixation system implantation kit, internal - intended to be used as accessories to the stryker spine navigation system, when used with the spinemap 3d navigation software. they are manual surgical instruments intended to be used in spine surgery to facilitate placement of stryker spine implants. may be used as part of the stryker spine navigation system, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. the system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. intended for exclusive use with the rotational navigational adaptor and associated trackers to facilitate the placement of the pedicle screws of the stryker spine xia? 3, xia? 4.5, mantis?, mantis? redux, and es2? spinal fixation systems using the stryker spinemap? 3d navigation system.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 45169 - stereotactic surgery system probe, reusable - an accessory to the mazor x system, the arm guides are intended to accommodate between medtronic spine instruments and navigation navlock trackers while using the mazor x system.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 58884 - self-care monitoring web-based application software - glooko is a data management software intended for use in home and professional settings to aid individuals with diabetes and their healthcare professionals in review, analysis and evaluation of device data to support an effective diabetes management programme. glooko connects to compatible medical devices and trackers to allow users to transfer their data to the glooko system. glooko is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice

Australija - anglų - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 45199 - stereotactic surgery system, multi-purpose - the electromagnetic (em) ent trackers are single-use sterile devices and are intended for use with the medtronic ent software to track the location of suctions, probes, and the head frame in either open or percutaneous procedures.