Canada - English - Health Canada

diagnostic green limited - indocyanine green - powder for solution - 25mg - indocyanine green 25mg - cardiac function

United States - English - NLM (National Library of Medicine)

novadaq technologies inc. - indocyanine green (unii: ix6j1063hv) (indocyanine green acid form - unii:c4v974v932) - indocyanine green 25 mg - for determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography. indocyanine green for injection usp contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides.

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human - vaccines - active immunisation against h5n1 subtype of influenza a virus.; this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain.; prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,

European Union - English - EMA (European Medicines Agency)

life molecular imaging gmbh - florbetaben (18f) - radionuclide imaging; alzheimer disease - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.neuraceq is a radiopharmaceutical indicated for positron emission tomography (pet) imaging of β amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for alzheimer’s disease (ad) and other causes of cognitive impairment. neuraceq should be used in conjunction with a clinical evaluation.a negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of ad.

Singapore - English - HSA (Health Sciences Authority)

marks (s) private limited - clinical chemistry - diagnostic automation/cortez diagnostics urine reagent strips (urs) for urinalysis are firm plastic strips to which several different reagent areas are affixed. depending on the product being used, cortez urine reagent strips provide tests for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, ph, protein, urobilinogen, nitrite and leukocytes in urine. test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid‐base balance, and bacteriuria

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

siemens medical solutions usa, inc, united states of america - diagnostic ultrasound system -

Ireland - English - HPRA (Health Products Regulatory Authority)

diagnostic green gmbh - indocyanine green - powder for solution for injection

Singapore - English - HSA (Health Sciences Authority)

ortho-clinical diagnostics singapore pte. ltd. - immunology - for the qualitative determination of total (igg and igm) antibodies to treponema pallidum (tp) specific antigens in human serum and plasma (heparin, edta and citrate) using the vitros eci/eciq/3600 immunodiagnostic systems and the vitros 5600/xt 7600 integrated systems.the presence of antibodies to treponema pallidum (tp) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of recent, past or treated syphilis infection.

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

ortho-clinical diagnostics australia pty ltd - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - vitros immunodiagnostic products hiv combo for the simultaneous qualitative detection of antibodies to human immunodeficiency virus types 1, including group m and o, and/or 2 (anti-hiv-1 and anti-hiv-2) and hiv p24 antigen in human serum and plasma (heparin and edta) in adults,pregnant women, adolescents and children, vitros immunodiagnostic products hiv combo reagent pack and calibrator for the simultaneous qualitative detection of antibodies to human immunodeficiency virus types 1, including group m and o, and/or 2 (anti-hiv-1 and anti-hiv-2) and hiv p24 antigen in human serum and plasma.